ADDISC lumbar disc prosthesis : Analytical and FEA testing of novel implants

The intact intervertebral disc is a six-freedom degree elastic deformation structure with shock absorption. 'Ball-and-socket' TDR do not reproduce these properties inducing zygapophyseal joint overload. Elastomeric TDRs reproduce better normal disc kinematics, but repeated core deformation causes its degeneration. We aimed to create a new TDR (ADDISC) reproducing healthy disc features. We designed TDR, analyzed (Finite Element Analysis), and measured every 500,000 cycles for 10 million cycles of the flexion-extension, lateral bending, and axial rotation cyclic compression bench-testing. In the inlay case, we weighted it and measured its deformation. ADDISC has two semi-spherical articular surfaces, one rotation centre for flexion, another for extension, the third for lateral bending, and a polycarbonate urethane inlay providing shock absorption. The first contact is between PCU and metal surfaces. There is no metal-metal contact up to 2000 N, and CoCr28Mo6 absorbs the load. After 10 million cycles at 1.2-2.0 kN loads, wear 140.96 mg (35.50 mm3), but no implant failures. Our TDR has a physiological motion range due to its articular surfaces' shape and the PCU inlay bumpers, minimizing the facet joint overload. ADDISC mimics healthy disc biomechanics and Instantaneous Rotation Center, absorbs shock, reduces wear, and has excellent long-term endurance

Biomechanical Assessment of Cervical Spine with Artificial Disc during Axial Rotation, Flexion and Extension

Background: The cervical spine is the most vulnerable part of the vertebral column and the rotational movements are the most dangerous movements which may cause damages to cervical spine. A good treatment option for the cervical disc disease is the replacement of a damaged disc with an artificial disc that has shown satisfactory clinical results.Methods: The C4 to C6 vertebrae of a normal subject and a person with an artificial disc between the vertebrae C5 and C6 were 3d modelled and then analyzed using FEM. The results of stress and deformationin both subjects were calculated and compared for three rotational head movements: axial rotation, flexion and extension. A distributed load of 73.6 N was used to simulate the head weight and a moment of 1.8 N.m was used to create all three rotational movements.Results: The maximum Von Mises stress in the normal subject during the axial rotation was respectively 2.2 and 1.8 times greater than the maximum stress during flexion and extension. These numbers were 2.6 and 2.3 in the subject with artificial disc.Following the artificial disc replacement, the cervical spine strength against the extension improved about 2.7%, however, the strength in axial rotation and flexion decreased 6.9% and 24.3%, respectively. The maximum values of deformation in the normal subject during flexion, extension and axial rotation were 2.8, 2.8 and 2 times of the values in the subject with artificial disc during the similar movements.Conclusion: The flexion and extension involve risks of hurting the cervical spine, however, the axial rotation is much more dangerous regarding the damages it may cause especially to the C5/6 intervertebral disc. Numerically, there is a much greater possibility of cervical spine injury during axial rotation

Finite element modeling and simulation of degeneration and hydrotraction therapy of human lumbar spine segments

A large percent of population is affected by low back pain problems all over the world, starting from the degeneration of the lumbar spinal structure, caused generally by ageing and mechanical overloading. If the degeneration is not too advanced, surgical treatments can be avoid, by applying conservative treatments, like traction therapies. Dry traction is a well-known method, however, often happens that instead of the traction effect and stress relaxation, the compression increases in the discs due to muscle activities. This verifies the importance of the suspension hydro-traction therapy, where the muscles are completely relaxed. The aim of this study was doubled: to model and simulate numerically the age-related and accidental degenerations of lumbar functional spinal units (FSU) and to simulate the mechanical answer of the more or less degenerated lumbar segments for the hydro-traction treatment, by using FE method. The basic question was: how to unload the disc to regain or improve its functional and metabolic ability. FE simulations of the mechanical behaviour of human lumbar FSUs with life-long agerelated and sudden accidental degenerations are presented for tension and compression. Compressive material constants were obtained from the literature, tensional material moduli were determined by parameter identification, using in vivo measured global elongations of segments as control parameters. 3D FE models of a typical FSU of lumbar part L3-S1 were developed extended to several nonlinear and nonsmooth unilateral features of intervertebral discs, ligaments, articular facet joints and attachments. The FE model was validated both for compression and tension, by comparing the numerical calculations with experimental results. The weightbath hydrotraction therapy decreases pain, increases joint flexibility, and improves the quality of life of patients with cervical or lumbar discopathy. Numerical simulations were investigated to clear the biomechanical effects of hydrotraction treatment of more or less degenerated segments to improve the efficiency of the non-invasive conservative treatment

design of a new intervertebral disc prosthesis a numerical approach

Abstract In the degenerative disc disease, an alternative treatment to the traditional arthrodesis, consisting in the fusion of the two adjacent vertebral bodies, is the artificial intervertebral disc. The advantage of an artificial intervertebral disc is that the d.o.f. of the vertebral segment can be saved and the mobility of the spine could be almost restored. Many solutions were proposed in the last decades, most of them consisting in metallic rigid joints able to assure the mobility and to maintain the correct distance between the vertebrae but subject to corrosion, wear and interface problems due to the different stiffness with the biological tissues. Purpose of this paper is the design of a prosthetic device substituting the disc to be placed in the intervertebral zone. Different types of artificial prostheses have been proposed by the authors, based on similarity with physiological discs, then with a central part (nucleus) made of hyperelastic material and an outer containment frame (annulus) consisting of a plastic material with a stiffness high enough to assure the reaction force and to avoid large radial displacements. In our solutions, the external parts (annulus and plates) were modeled by HDPE and the inner part (nucleus) by silicone and hydrogel. All the materials are highly biocompatible. The intention of the authors, moreover, is to permit an easier surgical technique. The prosthesis, in fact, could be mounted void of the nucleus, allowing an easier placement, and filled only after the frame insertion, by injecting the silicone through a syringe. The nucleus was modeled by the Mooney-Rivlin parameters related to elastomers, being the disc subject to large deformations that the materials have to be able to withstand in elastic conditions. The discs are subjected to compressive loads either in the mounting phase or, after the silicone filling, due to the physiological loads

Multi-objective design optimization of a mobile-bearing total disc arthroplasty considering spinal kinematics, facet joint loads, and metal-on-polyethylene contact mechanics

Total disc arthroplasty (TDA) is a motion-preserving surgical technique used to treat spinal disorders, when more conservative medical therapies fail. Unfortunately, a high incidence of revision surgery exists due to postoperative complications including abnormal kinematics, facet joint arthritis, and implant failures. However, TDA is still an attractive option, since an optimally designed artificial disc is expected to reproduce native segmental biomechanics. Correspondingly, it would mitigate the development of adjacent segment diseases (a major concern of spinal fusion) caused by altered segmental biomechanics. Design optimization is a process of finding the best design parameters for a component/system to satisfy one/multiple design requirements using optimization algorithms. The shape of a candidate design is parametrized using computer-aided design, such that design parameters are manipulated to minimize one/multiple objective functions subject to performance constraints and design space bounds. Optimization algorithms typically require the gradients of the objective/constraint functions with respect to each design variable. In the traditional design optimization, due to the high computational cost to calculate the gradients by performing finite element analysis in each optimization iteration, it often results in a slow process to seek the optimal solution. To address the problem, an artificial neural network (ANN) was implemented to derive the analytical expressions of the objective/constraint function and their gradients. By incorporating analytical gradients, we successfully developed a multiobjective optimization (MOO) framework considering three performance metrics simultaneously. Furthermore, a new mobile-bearing TDA design concept featuring a biconcave polyethylene (PE) core was proposed, to strengthen the PE rim, where a high risk of fracture exists. It was hypothesized that there is a trade-off relationship among postoperative performance metrics in terms of spinal kinematics, facet joint loading, and metal-on-polyethylene contact mechanics. We tested this hypothesis by refining the new TDA to match normal segmental biomechanics and alleviate PE core stress. After performing MOO, the best-trade-off TDA design was determined by the solved three-dimensional Pareto frontier. The novel MOO framework can be also used to improve existing TDA designs, as well as to push the cutting edge of surgical techniques for the treatment of spinal disorders

Alterations in lumbar spine mechanics due to degenerative disc disease

2010 Fall.Includes bibliographical references.Degenerative disc disease is a major source of low back pain. It is hypothesized to significantly alter the biomechanics of the lumbar spine both at the tissue and motion segment (multi-vertebral) levels. However, explicit correlations between the former and the latter has not been established, and this critical link is only possible through modeling the intervertebral disc tissue behavior within a constitutive framework and implementing it in a finite element model of the lumbar spine. In order to develop a better appreciation of the biomechanics of disc degeneration, the main objectives of this dissertation work were to investigate the degenerative disease related mechanical alterations on lumbar spine through finite element modeling and experimentation, and evaluate the contemporary treatment strategies. To meet this objective, a finite element model of the healthy human lumbar spine was generated based on computed tomography (CT) imagery. Mesh convergence was verified based on strain energy density predictions. Kinematic and mechanical predictions of clinical interest, including range of motion and intradiscal nuclear pressure, were validated under pure moment loading. The mechanical properties of healthy and degenerated annulus fibrosus tissue were quantified using an orthotropic continuum model, with empirical determination of the requisite material coefficients derived from biaxial and uniaxial tension tests. The resultant material models were implemented into the validated finite element model in order to simulate disc degeneration at the L3-L4 level. At the tissue level, degeneration was found to significantly increase the dispersion in the collagen fiber orientation and the nonlinearity of the fiber mechanical behavior. At the motion segment level, degeneration increased the mobility of the spine, with concomitant increases in the local stress predictions in the annulus and facet force transmission. Our results were in good agreement with the clinical findings of instability and injury to the intervertebral disc due to degeneration. Total disc replacement was also considered as a treatment option within the aforementioned finite element framework. The model predictions indicated that single and two-level disc replacement restored motion at the treated levels, while linearizing the kinematic response and increasing the facet force transmission. The data reflect that the successful surgical outcome is most likely obtained when maximum preservation of native disc tissue is achieved during implantation of the prosthetic device

Computationally Efficient Finite Element Models of the Lumbar Spine for the Evaluation of Spine Mechanics and Device Performance

Finite Element models of the lumbar spine are commonly used for the study of spine mechanics and device performance, but have limited usefulness in some applications such as clinical and design phase assessments due to long analysis times. In this study a computationally efficient L4-L5 FSU model and a L1-Sacrum multi-segment model were developed and validated. The FSU is a functional spine unit consisting of two adjacent vertebral bodies, in this case L4 and L5. The multi-segment model consists of all lumbar vertebrae and the sacrum. The models are able to accurately predict spine kinematics with significantly reduced analysis times, relative to fully deformable representations. Analysis times were reduced from 3 hrs and 20 min to 2 min and 1 min for the multi-segment and FSU models, respectively. The vertebrae geometries were reconstructed from CT scans of the cadaveric specimen. Prior to model development, experimental testing was performed on the specimen using a custom multi-axis spine simulator. Collection of kinematic data in response to external loading made tuning of the model stiffness possible. The improved computational efficiency of the models makes them more useful for applications requiring multiple iterations and short analysis times such as clinical and design phase assessments of implants. The model can also be used in efforts to develop lumbar musculoskeletal models, which may require multiple runs for the optimization of muscle forces

Human lumbar spine biomechanics: study of pathologies and new surgical procedures

This thesis aims to shed light on the process that undergoes the lumbar spine as a result of intervertebral disc degeneration and different lumbar surgeries, paying special attention on the main risk factors and how to overcome them. Low back pain is the leading musculoskeletal disorder in all developed countries generating high medical related costs. Intervertebral disc degeneration is one of the most common causes of low back pain. When conservative treatments fail to relieve this pain, lumbar surgery is needed and, in this regard, lumbar fusion is the \textquotedblleft gold standard\textquotedblright technique to provide stability and neural decompression.Degenerative disc disease has been studied through two different approaches. An in-vivo animal model was reproduced and followed-up with MRI and mechanical testing to see how the water content decreased while the stiffness of the tissue increased. Then, degeneration was induced in a single disc of the human lumbar spine and the effects on the adjacent disc were investigated by the use of the finite element models. Further on, different procedures for segmental fusion were computationally simulated. A comparison among different intersomatic cage designs, supplemented with posterior screw fixation or placed in a stand-alone fashion, showed how the supplementary fixation drastically decreased the motion in the affected segment increasing the risk of adjacent segment disease more than a single placed cage. However, one of the main concerns regarding the use of cages without additional fixation is the subsidence of the device into the vertebral bone. A parametric study of the cage features and placement pointed to the width, curvature, and position as the most influential parameters for stability and subsidence.Finally, two different algorithms for tissue healing were implemented and applied for the first time to predict lumbar fusion in 3D models. The self-repairing ability of the bone was tested after simple nucleotomy and after instrumentation with internal fixation, anterior plate or stand-alone intersomatic cage predicting, in agreement with previous animal and clinical studies, that instrumentation may be not necessary to promote segmental fusion. In particular, the intervertebral disc height was seen to play an important role in the bone bridge or osteophyte formation.To summarize, this thesis has focused in the main controversial issues of intervertebral disc degeneration and lumbar fusion, such as degenerative process, adjacent segment disease, segment stability, cage subsidence or bone bridging. All the models described in this thesis could serve as a powerful tool for the pre-clinical evaluation of patient-specific surgical outcomes supporting clinician decisions. This thesis aims to shed light on the process that undergoes the lumbar spine as a result of intervertebral disc degeneration and different lumbar surgeries, paying special attention on the main risk factors and how to overcome them. Low back pain is the leading musculoskeletal disorder in all developed countries generating high medical related costs. Intervertebral disc degeneration is one of the most common causes of low back pain. When conservative treatments fail to relieve this pain, lumbar surgery is needed and, in this regard, lumbar fusion is the \textquotedblleft gold standard\textquotedblright technique to provide stability and neural decompression. Degenerative disc disease has been studied through two different approaches. An in-vivo animal model was reproduced and followed-up with MRI and mechanical testing to see how the water content decreased while the stiffness of the tissue increased. Then, degeneration was induced in a single disc of the human lumbar spine and the effects on the adjacent disc were investigated by the use of the finite element models. Further on, different procedures for segmental fusion were computationally simulated. A comparison among different intersomatic cage designs, supplemented with posterior screw fixation or placed in a stand-alone fashion, showed how the supplementary fixation drastically decreased the motion in the affected segment increasing the risk of adjacent segment disease more than a single placed cage. However, one of the main concerns regarding the use of cages without additional fixation is the subsidence of the device into the vertebral bone. A parametric study of the cage features and placement pointed to the width, curvature, and position as the most influential parameters for stability and subsidence. Finally, two different algorithms for tissue healing were implemented and applied for the first time to predict lumbar fusion in 3D models. The self-repairing ability of the bone was tested after simple nucleotomy and after instrumentation with internal fixation, anterior plate or stand-alone intersomatic cage predicting, in agreement with previous animal and clinical studies, that instrumentation may be not necessary to promote segmental fusion. In particular, the intervertebral disc height was seen to play an important role in the bone bridge or osteophyte formation. To summarize, this thesis has focused in the main controversial issues of intervertebral disc degeneration and lumbar fusion, such as degenerative process, adjacent segment disease, segment stability, cage subsidence or bone bridging. All the models described in this thesis could serve as a powerful tool for the pre-clinical evaluation of patient-specific surgical outcomes supporting clinician decisions. <br /

A Virtual Model of the Human Cervical Spine for Physics-based Simulation and Applications

Utilizing recent advances in computer technology, Our Biomechanics Laboratory have made an effort to integrate computer animation and engineering analysis software into biomedical research, specifically towards simulation and animation of in vitro experimentation of the human cervical spine in the virtual world. The objectives of this study were to develop a virtual model of the human cervical spine for physics-based simulation and to apply the virtual model to studies of different surgical procedures and instrumentation. A process for creating an accurate virtual model of the human cervical spine was developed. The model consisted of seven vertebrae (C2-T1) connected with soft tissue components: intervertebral joint, facet joints, and ligaments. The soft tissue components were assigned nonlinear viscoelastic properties. The evaluation of the model included the percent contribution of rotation relative to global rotation, coupling behaviors, helical axes of motion pattern, global rotational stiffness curves, and animations of the disc and facet forces. This model was used to evaluate different mounting configurations for axial rotation testing and to identify a set of end constraint conditions that produced physiologic responses during axial rotational loading. This model was also used to simulate the biomechanical responses of single-level cervical fusion. The single-level fusion was found to produce increased motion compensation at the adjacent segments during flexion and extension. Greater increases in the disc forces were found in the spinal level superior to the fusion during flexion and inferior to the fusion during flexion extension. This model was also used to study of the biomechanical effects of different design features for cervical disc arthroplasty. A constrained spherical joint placed at the disc level significantly increased facet loads during extension. Lowering the rotational axis of the spherical joint into the subjacent body also caused a marginal increase in facet loading during flexion, extension, and lateral bending. Un-constraining the spherical joint to a plane at the disc level minimized facet load build up. The virtual model bridges the gap between the cadaveric-based in vitro tests and clinicalbased experimental studies to further the research and educational knowledge of cervical spine biomechanics