Volume 60, Issue 2

Magnetic resonance imaging (MRI) has great potential as an imaging modality for guiding minimally invasive interventions because of its superior soft tissue contrast and the possibility of arbitrary slice positioning while avoiding ionizing radiation and nephrotoxic iodine contrast agents. The major constraints are: limited patient access, the insufficient assortment of compatible instruments and the difficult device visualization compared to X-ray based techniques. For the latter, resonant MRI markers, fabricated by using the wire-winding technique, have been developed. This fabrication technique serves as a functional model but has no clinical use. Thus, the aim of this study is to illustrate a four-phase design process of resonant markers involving microsystems technologies. The planning phase comprises the definition of requirements and the simulation of electromagnetic performance of the MRI markers. The following technologies were considered for the realization phase: aerosol-deposition process, hot embossing technology and thin film technology. The subsequent evaluation phase involves several test methods regarding electrical and mechanical characterization as well as MRI visibility aspects. The degree of fulfillment of the predefined requirements is determined within the analysis phase. Furthermore, an exemplary evaluation of four realized MRI markers was conducted, focusing on the performance within the MRI environment.

Titanium-based alloys can be actively brazed onto bio-inert ceramics and potentially be used as biocompatible coatings. To further improve their bioactivity in vivo , introduction of calcium phosphate (CaP)-based granulates onto their surface layer is possible. For this, mechanically stable CaP-based granulates need to be able to withstand the demand of the brazing process. In this study, spherical granulates, made of a calcium phosphate composite composed primarily of β-tricalcium phosphate and hydroxyapatite, a bioactive glass, and a mixture of the previous two, were manufactured by spray drying. The influence of organic additives (Dolapix CE64, trisodium citrate) and solids content (30–80 wt%) in the slurry on the physical characteristics of granulates was investigated. X-ray diffraction, Brunauer, Emmett, Teller specific surface area standard method, scanning electron microscopy, granulate size analysis, and single granule strength were performed. Our results showed that trisodium citrate permitted the production of granulates with regular morphology, high density, and increased failure stress values. The strong granules also withstood the brazing process. These results show that CaP bioactive agents can be generated and be integrated during the demanding metallurgical processes, allowing for one-step bioactivation of metal brazes.

Skin tissue is not only responsible for thermoregulation but also for protecting the human body from mechanical, bacterial, and viral insults. The mechanical properties of skin tissue may vary according to the anatomical locations in the body. However, the linear elastic and nonlinear hyperelastic mechanical properties of the skin in different anatomical regions and at different loading directions (axial and circumferential) so far have not been determined. In this study, the mechanical properties during tension of the rat abdomen and back were calculated at different loading directions using linear elastic and nonlinear hyperelastic material models. The skin samples were subjected to a series of tensile tests. The elastic modulus and maximum stress of the skin tissues were measured before the incidence of failure. The nonlinear mechanical behavior of the skin tissues was also computationally investigated through a constitutive equation. Hyperelastic strain energy density function was calibrated using the experimental data. The results revealed the anisotropic mechanical behavior of the abdomen and the isotropic mechanical response of the back skin. The highest elastic modulus was observed in the abdomen skin under the axial direction (10 MPa), while the lowest one was seen in the back skin under axial loading (5 MPa). The Mooney-Rivlin material model closely addressed the nonlinear mechanical behavior of the skin at different loading directions, which can be implemented in the future biomechanical models of skin tissue. The results might have implications not only for understanding of the isotropic and anisotropic mechanical behavior of skin tissue at different anatomical locations but also for providing more information for a diversity of disciplines, including dermatology, cosmetics industry, clinical decision making, and clinical intervention.

Objective: To describe the principles and operation of a new telemetry-based function test for the Nucleus ® cochlear implant, known as the CS19 Intra-Cochlear Impedance Matrix (IIM) and to present results from a multicentre clinical study to establish reproducibility (test-retest reliability) and normative ranges. Method: The IIM test measures bipolar impedances between all electrode pairs and employs a normalization procedure based on common ground impedances in order to identify abnormal current paths among electrodes. Six European clinics collected IIM data from a total of 192 devices. Results: Reproducibility was high between initial and repeat measurements. The normative analysis demonstrated narrow ranges among devices after normalization of impedance data. The IIM is able to identify abnormal current paths that are not evident from standard impedance telemetry and may otherwise only be found utilising average electrode voltage measurements (AEV). Conclusions: The IIM test was found to be straightforward to perform clinically and demonstrated reproducible data with narrow ranges in normally-functioning devices. Because this test uses a very low stimulation level the IIM test is well suited for children or multiply handicapped CI users who cannot reliably report on their auditory percepts. The new algorithms show potential to improve implant integrity testing capabilities if implemented in future clinical software.

The detection limits for cortical and brain stem sources associated with the auditory pathway are examined in order to analyse brain responses at the limits of the audible frequency range. The results obtained from this study are also relevant to other issues of auditory brain research. A complementary approach consisting of recordings of magnetoencephalographic (MEG) data and simulations of magnetic field distributions is presented in this work. A biomagnetic phantom consisting of a spherical volume filled with a saline solution and four current dipoles is built. The magnetic fields outside of the phantom generated by the current dipoles are then measured for a range of applied electric dipole moments with a planar multichannel SQUID magnetometer device and a helmet MEG gradiometer device. The inclusion of a magnetometer system is expected to be more sensitive to brain stem sources compared with a gradiometer system. The same electrical and geometrical configuration is simulated in a forward calculation. From both the measured and the simulated data, the dipole positions are estimated using an inverse calculation. Results are obtained for the reconstruction accuracy as a function of applied electric dipole moment and depth of the current dipole. We found that both systems can localize cortical and subcortical sources at physiological dipole strength even for brain stem sources. Further, we found that a planar magnetometer system is more suitable if the position of the brain source can be restricted in a limited region of the brain. If this is not the case, a helmet-shaped sensor system offers more accurate source estimation.

Hadron therapy has already proven to be successful in cancer therapy, and might be a noninvasive alternative for the ablation of cardiac arrhythmias in humans. We present a pilot experiment investigating acute effects of a 12 C irradiation on the AV nodes of porcine hearts in a Langendorff setup. This setup was adapted to the requirements of charged particle therapy. Treatment plans were computed on calibrated CTs of the hearts. Irradiation was applied in units of 5 and 10 Gy over a period of about 3 h until a total dose of up to 160 Gy was reached. Repeated application of the same irradiation field helped to mitigate motion artifacts in the resulting dose distribution. After irradiation, PET scans were performed to verify accurate dose application. Acute AV blocks were identified. No other acute effects were observed. Hearts were kept in sinus rhythm for up to 6 h in the Langendorff setup. We demonstrated that 12 C ions can be used to select a small target in the heart and, thereby, influence the electrical conduction system. Second, our pilot study seems to suggest that no adverse effects have to be expected immediately during heavy ion irradiation in performing subsequent experiments with doses of 30–60 Gy and intact pigs.

To extend the indications of intramedullary nails for distal or proximal fractures, nails with angle stable locking options have been developed. Studies on the mechanical efficacy of these systems have been inconsistent likely due to confounding variables such as number, geometry, or orientation of the screws, as well as differences in the loading mode. Therefore, the aim of this study was to quantify the effect of angular stability on the mechanical performance of intramedullary nails. The results could then be compared with the effects of various locking screw parameters and loading modes. A generic model was developed consisting of artificial bone material and titanium intramedullary nail that provided the option to systematically modify the locking screw configuration. Using a base configuration, the following parameters were varied: number of screws, distance and orientation between screws, blocking of screws, and simulation of freehand locking. Tension/compression, torsional, and bending loads were applied. Stiffness and clearance around the zero loading point were determined. Angular stability had no effect on stiffness but completely blocked axial clearance (p=0.003). Simulation of freehand locking reduced clearance for all loading modes by at least 70% (p<0.003). The greatest increases in torsional and bending stiffness were obtained by increasing the number of locking screws (up to 80%, p<0.001) and by increasing the distance between them (up to 70%, p<0.001). In conclusion, our results demonstrate that the mechanical performance of IM nailing can be affected by various locking parameters of which angular stability is only one. While angular stability clearly reduces clearance of the screw within the nail, mechanical stiffness depends more on the number of screws and their relative distance. Thus, optimal mechanical performance in IM nailing could potentially be obtained by combining angular stability with optimal arrangement of locking screws.

Femoroplasty is theoretically a prophylactic surgical procedure for femoral neck fracture. Although bone cement is generally used for augmentation, its distribution cannot be easily controlled. This study investigated whether a bioactive screw is feasible for femoroplasty as an alternative augmentation material. A mechanical test was done to compare the strength of four types of augmentation bioactive screw (Superfixsorb), two bioinert cements, or no intervention in a composite femoral bone. The peak load to fracture under simulated falling was compared among the four groups. The mean peak load to failure in the bioactive screw group (2667 N) was significantly higher than that in the intact group (2391 N) (p=0.028), comparable to that in the Simplex P cement group (2864 N) (p=0.11), and significantly lower than that of the cranioplastic cement group (3022 N) (p=0.006). The strength of a composite femur with the bioactive screw was higher than that of an intact bone and comparable to one cement augmentation. Thus, this bioactive screw can be potentially used as augmentation material for femoroplasty.

The position of the trunk can be negatively affected by many diseases. This work focuses on a noninvasive method of quantifying human postural stability and identifying defects in balance and coordination as a result of the nervous system pathology. We used a three-degree-of-freedom orientation tracker (Xsens MTx unit) placed on a patient’s trunk and measured three-dimensional (3-D) data (pitch, roll, and yaw) during quiet stance. The principal component analysis was used to analyze the data and to determine the volume of 3-D 95% confidence ellipsoid. Using this method, we were able to model the distribution of the measured 3-D data (pitch, roll, and yaw). Eight patients with degenerative cerebellar disease and eight healthy subjects in this study were measured during stance, with eyes open and eyes closed, and statistical analysis was performed. The results of the new method based on the 3-D confidence ellipsoid show that the volumes related to the patients are significantly larger than the volumes related to the healthy subjects. The concept of confidence ellipsoid volume, although known to the biomechanics community, has not been used before to study the postural balance problems. The method can also be used to study, for example, head and pelvis movements or alignments during stance.