Temperature-dependent tensile properties of polyamide 12 for the use in percutaneous transluminal coronary angioplasty balloon catheters.

BACKGROUND: Percutaneous transluminal coronary angioplasty (PTCA) balloon catheters must withstand high pressures required for the lesion treatment, pushing loads during insertion, and pulling loads during withdrawal. These loads pose a challenge especially for polymeric tubular shafts with small cross sections. In order to enable new design innovations and to better understand the mechanics of current catheter technologies, the tensile properties of polyamide (PA) 12 were investigated. PA 12 dog bone specimens and medical PA 12 tubes were either stored at ambient temperature and humidity or conditioned in water, and subjected to tensile loads at different temperatures. In addition, the effect on the tensile properties of the necking process, a forming process to reduce the wall thickness of the tubes, was determined. RESULTS: The tested tubes showed a reduction in both Young's Modulus (- 41.5%) and yield stress (- 29.2%) compared to standardized specimens. Furthermore, an increase in temperature and water absorption softens the material and reduces the mechanical properties like the Young's Modulus and the yield stress. It was found that the material strengthens during the necking process. Likely due to the orientation of the polymers chain molecules in load direction (Rösler et al., 2007), the Young's Modulus of the material could be increased by 43.5%. Furthermore, the absence of a yield point after necking allows for a greater loading capacity of the material without unstable neck growth. Besides the strengthening, the ultimate strain is reduced by 50%. This indicates that the necking process induces plastic deformation. CONCLUSION: The investigation showed that the environmental conditions like temperature and humidity can influence mechanical properties. It could also be shown that pre-forming processes such as necking can enhance the mechanical properties, such as the Young's Modulus, while reducing the wall thickness. These findings suggest possible further development of catheters with a small cross section and higher mechanical strength and highlight the importance to account for the targeted operating temperature during the design process.

Determination of the translational and rotational stiffnesses of an L4-L5 functional spinal unit using a specimen-specific finite element model.

The knowledge of spinal kinematics is of paramount importance for many aspects of clinical application (i.e. diagnosis, treatment and surgical intervention) and for the development of new spinal implants. The aim of this study was to determine the translational and rotational stiffnesses of a functional spinal unit (FSU) L4-L5 using a specimen-specific finite element model. The results are needed as input data for three-dimensional (3D) multi-body musculoskeletal models in order to simulate vertebral motions and loading in the lumbar spine during daily activities. Within the modelling process, a technique to partition the constitutive members and to calibrate their mechanical properties for the complex model is presented. The material and geometrical non-linearities originating from the disc, the ligaments and the load transfer through the zygapophysial joints were considered. The FSU was subjected to pure moments and forces in the three anatomical planes. For each of the loading scenarios, with and without vertical and follower preload, the presented technique provides results in fair agreement with the literature. The novel representation of the nonlinear behaviour of the translational and rotational stiffness of the disc as a function of the displacement can be used directly as input data for multi-body models.

Resistance of equine tibiae and radii to side impact loads.

REASONS FOR PERFORMING STUDY: There are no detailed studies describing the resistance of equine tibiae and radii to side impact loads, such as a horse kick and a better understanding of the general long bone impact behavioural model is required. OBJECTIVES: To quantify the typical impact energy required to fracture or fissure an equine long bone, as well as to determine the range and time course of the impact force under conditions similar to that of a horse kick. METHODS: Seventy-two equine tibiae and radii were investigated using a drop impact tester. The prepared bones were preloaded with an axial force of 2.5 kN and were then hit in the middle of the medial side. The impact velocity of the metal impactor, weighting 2 kg, was varied within the range of 6-11 m/s. The impact process was captured with a high-speed camera from the craniomedial side of the bone. The videos were used both for slow-motion observation of the process and for quantifying physical parameters, such as peak force via offline video tracking and subsequent numerical derivation of the 'position vs. time' function for the impactor. RESULTS: The macroscopic appearance of the resultant bone injuries was found to be similar to those produced by authentic horse kicks, indicating a successful simulation of the real load case. The impact behaviours of tibiae and radii do not differ considerably in terms of the investigated general characteristics. Peak force occurred between 0.15-0.30 ms after the start of the impact. The maximum contact force correlated with the 1.45-power of the impact velocity if no fracture occurred (F(max) ≈ 0.926 · v(i) (1.45) ). Peak force scatter was considerably larger within the fractured sub-group compared with fissured bones. The peak force for fracture tended to lie below the aforementioned function, within the range of F(max) = 11-23 kN ('fracture load'). The impact energy required to fracture a bone varied from 40-90 J. CONCLUSIONS: The video-based measuring method allowed quantifying of the most relevant physical parameters, such as contact force and energy balance. POTENTIAL RELEVANCE: The results obtained should help with the development of bone implants and guards, supporting theoretical studies, and in the evaluation of bone injuries.

Proof testing of ceramic femoral heads for hip joint implants.

A proof test procedure for the rejection of defective ceramic hip ball heads in the production line is presented. The procedure consists of applying a load to each ceramic ball head. This load, being somewhat higher than the maximum physiological load, should not cause any damage in cases where the highly stressed areas are free of flaws. In this procedure, a polymer ring is positioned inside the ball head bore between a socket and the head of a tie bolt. Once the tie bolt is pulled downwards, the ring creates a radial pressure on the inner bore surface of the ball head. With an iterative approach based on finite element analysis, the proof test design was optimized in order to obtain a stress distribution in the ball head similar to that resulting in in vivo conditions. The calculated results were validated by strain gauge measurements performed on an assembled proof test apparatus. Several polymers were considered for the ring. Ultrahigh-molecular-weight polyethylene (UHMWPE grade RCH 1000) showed the best durability properties and lowest wear rates. The requirement to perform 1000 reruns without significant reduction of stress in the ball head was fulfilled. Although other proof test procedures for ceramic femoral heads already exist, the procedure presented in this article shows advantages concerning maintenance and operating costs.

Parameter study for the finite element modelling of long bones with computed-tomography-imaging-based stiffness distribution.

Four radii of different horses were tested in three-point bending and in pure torsion. Detailed finite element (FE) models of these long bones were established by means of computed-tomography (CT) images and tests simulated for both load cases. For the allocation of the local isotropic material stiffness, individual exponential functions were applied whose factor and exponent were determined solely by fitting them to the measured torsional stiffness and bending stiffness of the entire bones. These stiffness functions referring directly to the CT number and having exponents between 1.5 and 2 were in good agreement with Young's moduli subsequently measured from small samples cut from the investigated bones. Based on a model with local orthotropic material definition, an additional parameter study was conducted to verify the sensitivities of the FE analysis results on single variations in the orthotropic elastic constants. This study revealed that the bending test simulations could be enhanced by substantial reduction in Young's moduli in the directions perpendicular to the bone axis; thus, orthotropic material definition is preferable for the FE analysis of long bones.

Tribological behavior of DLC-coated articulating joint implants.

Coatings from diamond-like carbon (DLC) have been proven to be an excellent choice for wear reduction in many technical applications. However, for successful adaption to the total joint replacement field, layer performance, stability and adhesion in realistic physiological setups are quintessential and these aspects have not been consistently researched. In our team's efforts to develop long-term stable DLC implant coatings, test results gained from a simplified linear spinal simulator setup are presented. It is shown that metal-on-metal (MoM) pairs perform well up to 7 million loading cycles, after which they start to generate wear volumes in excess of 20 times those of DLC-coated implants. This is attributed to the roughening observed on unprotected metal surfaces. Furthermore, we illustrate that in contrast to DLC-on-DLC, MoM tribopairs require protein-containing media to establish low-friction conditions. Finally, results of defect monitoring during testing are presented, showing catastrophic failure of layers whose interfaces are too weak with respect to the stress-corrosion-cracking mechanism encountered in vivo.

Optimization of the stress distribution in ceramic femoral heads by means of finite element methods.

Ceramic ball heads for total hip replacement are highly loaded in vivo and must meet the sternest requirements concerning strength and safety. High stresses inside the ball head originate from the press fit between the conical stem (made of titanium alloy or steel) and the borehole of the ball. The aim of this study was the development of an optimized contour at the fillet inside the ball head by means of numerical methods, in order to reduce local stress concentrations. The computer-aided optimization method was applied on the customary engineering fillet radius to reduce local stress peaks. The local notch stress of the examined ball head design was reduced by up to 27 per cent for the relevant load cases. Verification by rupture testing of prototypes turned out to be difficult for axisymmetric load cases, since the static fracture load is governed by the hoop stresses in the contact area of the taper (global maximum), thus making it difficult to prove a local improvement. The sensitivity of the design to asymmetric loading was clearly shown (varying the load angle and bearing type). Stress relocation in the ball-stem interface at higher burst loads indicated the necessity of optimizing each ceramic femoral head design individually (i.e. for different borehole depths).

Influence of contaminants in the stem-ball interface on the static fracture load of ceramic hip joint ball heads.

The probability of in-vivo failure of ceramic hip joint implants is very low (0.05-0.004 per cent). Besides material flaws and overloading, improper handling during implantation may induce fractures of the ceramic ball head in the long term. This study focuses on the influence of contaminants located in the stem-ball interface and on the use of damaged metal tapers on the strength of ceramic ball heads. Mechanical tests on alumina ball heads according to the standard ISO 7206-10 were performed to identify their effect on the static fracture load. A decrease of up to 90 per cent with respect to the reference static fracture load was found when contaminants such as bone chips, soft tissue, or blood were present. Reductions of 57 per cent and 27 per cent were observed for deformed stem cross-sections (from circular to elliptical) and for flattened stems respectively, making deformed stems another influential parameter. Since any alteration of the interface between the metal taper and the ceramic ball head yields a nonuniform load introduction and hence results in stress concentrations, its presence has to be avoided.