Design of a surgical instrument for removing bone to provide screw access to a spinal fusion cage.

A surgical instrument to aid implantation of a range of lumbar spinal fusion cages has been developed. Once the cage is in position, the entrance to screw holes is partially blocked by the edge of the vertebral body. In order to insert fixation screws to secure the cage between the vertebrae, some part of the blocking edge has to be removed. Rongeurs are currently being used, but they can be time consuming and have the disadvantage that they may remove more bone than is necessary and may cause damage to the fusion cage if not used with care. In addition, access around some of the screw holes may be difficult. The aim of this instrument was to overcome these shortcomings. This paper describes the design of a surgical instrument for cutting edges from vertebral bodies. The development and evaluation of concept designs are presented and discussed. Potential risks were considered and modifications were performed on the selected concept. Functional prototypes were manufactured and tested on sheep lumbar vertebrae. The results showed that the newly designed cutting instrument functions as required and removes the required amount of bone from the vertebral body edge.

Effect of side holes in cervical fusion cages: a finite element analysis study.

The objective of this study was to investigate the effect of side holes on the predicted von Mises stress levels in cervical spinal fusion cages subjected to compressive loading. Models with between zero and ten side holes were developed. Finite element analysis (FEA) was used to simulate compression of the cage, made from the polymer PEEK (polyetheretherketone), between two adjacent vertebrae. The analyses were validated by experimental tests. In all of the models, the von Mises stress was highest at the cage-vertebrae interface with peak stresses of between 14 and 18 MPa. Increasing the Young's modulus of the vertebrae from 12 to 30 GPa increased the peak stress on average by 29 per cent. The stresses in the models were lower than the compressive strength of PEEK (118 MPa), and are well within the PEEK fatigue strength reported (60 MPa at 10 million cycles). This study suggests that the number of side holes had a negligible effect on the stress distribution within the cage; the stress magnitudes were fairly constant across all of the models and did not change substantially with the number of holes. Hence, a cervical cage with side holes is unlikely to fail in compression.

Amianthoid change: orientation of normal collagen fibrils during aging.

High-angle x-ray diffraction provides direct evidence that amianthoid change, occurring during aging of costal cartilage, corresponds to a transformation from an isotropic to a marked anisotropic distribution of collagen fibrils. Low-angle x-ray diffraction and electron microscopy show that the fibrils have the customary 67-nanometer axial periodicity. Electron microscopy shows that wide amianthoid collagen fibrils consist of smaller parallel fibrils fused together. Similarities between amianthoid change and tendon morphogenesis are briefly discussed. Amianthoid change is remarkable in that aging is accompanied by increased order.

Mucopolysaccharides: comparison of chondroitin sulfate conformations with those of related polyanions.

X-ray diffraction shows that chondroitin 6-sulfate, and some further rulfated derivatives, can occur in two ordered structures in stretched films. Both structures contain single helices with similar projected disaccharide lengths (9.6 and 9.8 angstroms) but with very different turn angles between successive disaccharides (120 and 45 degrees). In contrast, coaxial double helices of hyaluronates and t-carrageenates have shorter projected disaccharide lengths (8.5 and 8.9 angstroms).

Accelerated aging for testing polymeric biomaterials and medical devices.

Elevated temperature is frequently used to accelerate the aging process in polymers that are associated with medical devices and other applications. A common approach is to assume that the rate of aging is increased by a factor of 2(DeltaT/10), where DeltaT is the temperature increase. This result is a mathematical expression of the empirical observation that increasing the temperature by about 10 degrees C roughly doubles the rate of many polymer reactions. It is equivalent to assuming that the aging process is a first order chemical reaction with an activation energy of 10R/log(e)2, where R is the universal gas constant. A better approach would be to determine the activation energy for the process being considered but this is not always practicable. The simple approach does not depend on the temperature increase, provided that it is not so great that it initiates any physical or chemical process that is unlikely to be involved in normal aging. If a temperature increment theta were to increase a given polymer reaction rate n times, then an elevated temperature would increase the rate of aging by a factor of n(DeltaT/theta).

Finite element modelling of the Ilizarov external fixation system.

This study describes a computational method for predicting the mechanical response of any configuration of the Ilizarov external fixation system. Mechanical testing of each of the individual components (ring, threaded rod, and wire) of the Ilizarov system was used to determine the stiffness of each component. Finite element (FE) analysis was then used to model each of the individual components. Each model was tuned to match the mechanical testing. A modular FE modelling system, using a master input file, was then developed where the tuned FE models of the individual components could be generated, positioned, and interconnected to replicate a range of fixator configurations. The results showed that the stiffness predications from the FE modelling of the fixator configurations were consistently 10 per cent higher than the stiffness values obtained from the mechanical testing. The FE modelling system can be used to predict the characteristic response of the fixator configurations and clearly shows the relative changes in that response for variations in the number of components used.

Determination of the pressure required to cause mitral valve failure.

A method has been developed for applying water pressure to a closed mitral valve on the side corresponding to the heart's left ventricle. The pressure is increased until fluid flows through the valve, i.e. until it fails. A specific dissection technique has been developed to produce a specimen with two annular rings, mitral annulus and papillary muscle annulus. Since the valve is maintained intact, with its leaflets attached to papillary muscles by the chordae tendineae, this method allows the effects of ruptured chordae and their surgical repair or replacement to be assessed in vitro. The chamber that holds the valve supports both the mitral annulus and papillary muscle annulus of the specimen. The mitral annulus is sutured onto rubber sheeting held in the chamber. The papillary muscle annulus is held in place by a Perspex support. The main part of the apparatus consists of a water pump connected through flexible tubing to the chamber that holds the valve in place. The pressure at failure is measured using a pressure transducer. Preliminary experiments demonstrate that anterior leaflet marginal chordae, but not strut chordae, are vital to valve function. Posterior leaflet chordae have been found to be important for valve competence.

Mechanical properties of calcium sulphate/hydroxyapatite cement.

Setting times, volume after setting, injectability and hardness (at 37 degrees C in contact with Ringer's solution) were determined for cements made of mixtures of calcium sulphate hemihydrate (CS) and hydroxyapatite (HA) with a range of compositions. The purpose of these experiments was to determine the behaviour of a mixture that could be used as an injectable cement for orthopaedic applications, including spinal fusion. A suitable mixture consisted of 60% CS and 40% HA by mass; a slurry was made by mixing solid (36 g) with water (15 cm(3)). The slurry had initial and final setting times of 5.7+/-1.3 min and 19.6+/-0.7 min (mean +/- standard deviation), respectively. The hardness of the cement did not systematically increase or decrease in the 72 h following the final setting time. The volume of the cement was 99.8+/-0.4% of the volume of the initial slurry, i.e. there was negligible shrinkage on setting. It was able to withstand a pressure of 7.3+/-1.2 MPa, applied by a hemispherical indenter before the onset of permanent damage, indicating adequate strength for spinal fusion.

Collagen fibre orientation in the annulus fibrosus of intervertebral disc during bending and torsion measured by x-ray diffraction.

X-ray diffraction has been used to measure the orientation of the collagen fibres in the ventral annulus fibrosus of intact L 1/2 rabbit intervertebral discs during in vitro bending and torsion. Fibres are tilted with respect to the axis of the spine. As predicted by theory, fibre tilt decreases in those regions of the annulus which are stretched by bending but increases in the slackened regions. Good agreements with the quantitative predictions of bending theory was obtained in three of the six series of experiments, the predicted trend being found in all six. Tilt direction alternates in successive lamellae of the annulus. When discs were subjected to both clockwise and counterclockwise torsion of 5 degrees, the two families of tilted fibres reoriented in the expected directions.

X-ray diffraction demonstrates reorientation of collagen fibres in the annulus fibrosus during compression of the intervertebral disc.

The annulus fibrosus of the intervertebral disc is reinforced by tilted collagen fibres. It has been predicted that the tilt angle should increase as the disc was compressed. This prediction has now been confirmed using X-ray diffraction. Diffraction patterns were recorded from the ventral annulus of intact L1/2 rabbit discs during various stages of compression. At each stage the ventral height was measured. Fibre tilts were measured from the diffraction patterns and found to increase as the disc was compressed. For five out of six discs the quantitative dependence of tilt on compressed height was in good agreement with theoretical predictions; the sixth did not compress evenly but an increase in tilt was still observed.

Structure of bovine milk calcium phosphate determined by X-ray absorption spectroscopy.

Calcium in cow's milk is mainly in the form of calcium phosphate-phosphoprotein complexes known as casein micelles. These micelles, in contrast to other phosphoprotein complexes in bone and other tissues, can be readily isolated and studied, but conventional techniques have given ambiguous and conflicting evidence on the structure of milk calcium phosphate. Extended X-ray absorption fine structure and near-edge structure measurements at the newly commissioned Synchrotron Radiation Source at Daresbury indicate that it closely resembles brushite, CaHPO4 X 2H2O. This result, and chemical analysis, requires that phosphate groups from the matrix phosphoproteins be incorporated in the brushite lattice, probably in the surface, suggesting that these organic phosphate groups act as heterogeneous nucleation sites for phase separation of the calcium phosphate from solution.

Low angle X-ray diffraction studies on stained rat tail tendons.

Low angle X-ray diffraction patterns of rat tail tendons with heavy metal stains added were examined to help clarify the effects of fixation and staining on collagen fibrils. Fixing and staining of rat tail tendon fibers gives an X-ray pattern with an intensified 3.8 nm row and the preservation of most equatorial features found in the native pattern. The presence of the native pattern features suggests the value of fixation in preserving native structure before staining. Staining of rat tail tendon fibers without prior fixation led to the disappearance of the native equatorial features and the appearance of a new broad row line corresponding to a spacing of around 10.0--17.5 nm. This observation suggests that some alteration has taken place in the native structure and may be related to electron microscopic observations of units of 10.0--20.0 nm in collagen fibrils under some disruptive or developmental conditions.

Influence of fibril taper on the function of collagen to reinforce extracellular matrix.

Collagen fibrils provide tensile reinforcement for extracellular matrix. In at least some tissues, the fibrils have a paraboloidal taper at their ends. The purpose of this paper is to determine the implications of this taper for the function of collagen fibrils. When a tissue is subjected to low mechanical forces, stress will be transferred to the fibrils elastically. This process was modelled using finite element analysis because there is no analytical theory for elastic stress transfer to a non-cylindrical fibril. When the tissue is subjected to higher mechanical forces, stress will be transferred plastically. This process was modelled analytically. For both elastic and plastic stress transfer, a paraboloidal taper leads to a more uniform distribution of axial tensile stress along the fibril than would be generated if it were cylindrical. The tapered fibril requires half the volume of collagen than a cylindrical fibril of the same length and the stress is shared more evenly along its length. It is also less likely to fracture than a cylindrical fibril of the same length in a tissue subjected to the same mechanical force.

Wire tension in the Ilizarov system: accuracy of the wire-tensioning device.

The Ilizarov fixator consists of tensioned wires that attach bone segments to a modular frame. The aim of this study was to establish the accuracy and precision of the wire-tensioning device supplied with the Ilizarov external fixation system. The device was used to tension a wire in direct opposition to a calibrated load cell. Five subjects tested three devices, at each of their four tension settings, in two separate sessions. Subjects could not see the true tension during the test. There were significant differences between the results for different subjects (p < 0.01) and instruments (p < 0.01) but not for different tension settings or between the two sessions. Overall mean measured tensions were 4.9 per cent (standard deviation, 4.4 per cent) below intended values. Tensions obtained at the maximum edge (completely occluded) on the scale markings were significantly (p < 0.001) closer to the nominal values (mean discrepancy, 3.6 per cent) than those at the minimum edge (mean discrepancy, 17.6 per cent). Several factors influence wire tension. Tensioning devices are not identical and the results obtained with them depend on the user. If the scale markings are completely occluded, the discrepancy between intended and actual tensions of around 5 per cent is likely to be adequate for clinical practice since surgeons do not select the most suitable tension following quantitative data assessment, but rather it is a judgement based on surgical experience and consideration for the patient weight and expected level of activity.

Preventing encrustation in indwelling urethral catheters.

Encrustation is the main problem encountered with indwelling urethral catheters. A promising new approach to overcoming this problem is described here, which may have implications for catheter design.

A simple model for the function of proteoglycans and collagen in the response to compression of the intervertebral disc.

The nucleus pulposus of the intervertebral disc exerts a pressure which enables it to support axial compression when contained by the annulus fibrosus. The disc was modelled as a thick-walled cylindrical pressure vessel in which the nucleus was contained radially by the annulus. As a result, the stress in the annulus had radial (compressive) as well as tangential (tensile) components. The radial stress at a given point in the annulus was considered to be balanced by the internal pressure which is expected to arise from the attraction of water by proteoglycans. There was a reasonable agreement between the calculated radial stress distribution and published results on the distribution of water within the annulus. As the internal pressure is expected to be isotropic, the annulus was expected to contribute to the axial resistance to compression of the disc; this contribution would be equal, in magnitude, to the radial stress. Predictions of the pressure distribution within the annulus were similar to published experimental measurements made in the radial and axial directions. The tangential stress within the annulus was considered to arise from the restoring stress in its strained collagen fibrils.

Euler buckling as a model for the curvature and flexion of the human lumbar spine.

The upright thoraco-lumbar spine resembles an Euler column buckled in the second mode (n = 2) when viewed in the sagittal plane. An advantage of n = 2 buckling is that further load can be carried without adopting a stooped posture. Flexion of the spine is considered as the first quarter cycle of an Euler pendulum. This is possible if the antagonistic muscles which control movement increase the bending stiffness, EI, to a value of about 15 N m2. If the muscles are incapable of increasing EI sufficiently to support the weight of the body, or any excess load, the spine will be dynamically unstable. This conclusion is consistent with a static model which considers spinal instability as 'loss of stiffness' and a dynamic model which suggests that it arises from ineffective adaptive control. The flexed spine resembles an n = 1 buckled column.

Measurement of lumbar spine flexion-extension using a low-field open-magnet magnetic resonance scanner.

RATIONALE AND OBJECTIVES: The authors investigated the feasibility of using a low-field open-magnet magnetic resonance (MR) scanner to acquire functional flexion-extension images for range of motion (ROM) measurements on the lumbar spine. METHODS: Seventeen healthy subjects with no symptoms of back pain (age range, 22-59 years) were scanned in a low-field open-magnet MR scanner in the flexed, neutral, and extended positions. Each image was downloaded to a computer workstation for subsequent flexion-extension, lordosis, and ROM measurement. RESULTS: Data from two subjects were not analyzed because their images did not show all the lumbar vertebrae. For the remaining 15, there was a large variation in the magnitude of the ROM values (range, 9 degrees-70 degrees; mean 36.4 degrees, SD 16.5 degrees). However, there was a significant correlation between age and ROM (r = -0.63; P < 0.05). CONCLUSIONS: The low-field open-magnet MR scanner provides a method for noninvasive imaging of the lumbar spine, allowing the subject freedom of movement in the horizontal plane. This enables functional flexion-extension images of the lumbar spine to be acquired.

Light-scattering methods for antibiotic sensitivity tests.

The total intensity of light scattered in the angular range 30 degrees-130 degrees by a suspension of bacteria can be used as the basis of a method of antibiotic sensitivity testing. A procedure is given in which the bacteria are incubated in the presence of antibiotic, as a test, and in its absence, as a control, for 60 minutes. An incubation time of 90 minutes gives slightly more reliable results. With this increased incubation time it is necessary to measure the intensity of scattered light only at a single fixed angle or, at most, a few angles. Measuring the angular dependence of the scattered intensity does not allow the incubation period to be reduced.