Manfred Bijak

Basic design and construction of the Vienna FES implants : existing solutions and prospects for new generations of implants

We can distinguish 3 generations of FES implants for activation of neural structures: 1. RF-powered implants with antenna displacement dependent stimulation amplitude; 2. RF-powered implants with stabilised stimulation amplitude; and 3. battery powered implants. In Vienna an 8-channel version of the second generation type has been applied clinically to mobilisation of paraplegics and phrenic pacing. A 20-channel implant of the second generation type for mobilisation of paraplegics and an 8-channel implant of the third generation type for cardiac assist have been tested in animal studies. A device of completely new design for direct stimulation of denervated muscles is being tested in animal studies. There is a limited choice of technologically suitable biocompatible and bioresistant materials for implants. The physical design has to be anatomically shaped without corners or edges. Electrical conductors carrying direct current (D.C.) have to be placed inside a hermetic metal case. The established sealing materials, silicone rubber and epoxy resin, do not provide hermeticity and should only embed DC-free components. For electrical connections outside the hermetic metal case welding is preferable to soldering; conductive adhesives should be avoided. It is advisable to use a hydrophobic oxide ceramic core for telemetry antenna coils embedded in sealing polymer. Cleaning of all components before sealing in resin is of the utmost importance as well as avoidance of rapid temperature changes during the curing process.

Biomechanical Comparison of Modified Kessler and Running Suture Repair in 3 Different Animal Tendons and in Human Flexor Tendons

PURPOSE To establish the animal flexor tendon that best mimics the biomechanical performance of human flexor tendons. We investigated the biomechanical behavior of core and running sutures in 3 different animal flexor tendons and in human flexor tendons. Additionally, we attempted to help standardize future flexor tendon studies. To that purpose, nearly all variables occurring in the test setup have been highlighted. METHODS The species selected were pig, calf, sheep, and human. Two groups were formed. In the first group we tested 3-0 core sutures (Ticron; Tyco Healthcare, Vienna, Austria), and in the second group we tested 5-0 running sutures (Ethilon; Ethicon, Vienna, Austria). In each group, 10 tendons of each specimen were tested, which yielded a total of 80 tendons. In each group, the repaired tendons were subjected to 3,000 linear load cycles at a load of 15 N. At the end of this procedure, final gap values were recorded. In the next step, ultimate load-to-failure data were obtained from each specimen. RESULTS Core sutures behaved similarly in the human, sheep, and pig tendons with respect to ultimate loads. With respect to gap formation, core sutures behaved similarly in the human, sheep, and calf tendons. Deep running sutures behaved similarly in the human, sheep, and pig tendons in terms of ultimate load to failure. CONCLUSIONS In this study, sheep tendons were found to best mimic the biomechanical behavior of human tendons. Calf tendons seem to be unsuitable. There is a strong need for consistency in biomechanical test setups.

Safe neuromuscular electrical stimulator designed for the elderly.

A stimulator for neuromuscular electrical stimulation (NMES) was designed, especially suiting the requirements of elderly people with reduced cognitive abilities and diminished fine motor skills. The aging of skeletal muscle is characterized by a progressive decline in muscle mass, force, and condition. Muscle training with NMES reduces the degradation process. The discussed system is intended for evoked muscle training of the anterior and posterior thigh. The core of the stimulator is based on a microcontroller with two modular output stages. The system has two charge-balanced biphasic voltage-controlled stimulation channels. Additionally, the evoked myoelectric signal (M-wave) and the myokinematic signal (surface acceleration) are measured. A central controller unit allows using the stimulator as a stand-alone device. To set up the training sequences and to evaluate the compliance data, a personal computer is connected to the stimulator via a universal serial bus. To help elderly people handle the stimulator by themselves, the user interface is kept very simple. For safety reasons, the electrode impedance is monitored during stimulation. A comprehensive compliance management with included measurements of muscle activity and stimulation intensity enables a scientific use of the stimulator in clinical trials.

Pruritometer 2: Portable recording system for the quantification of scratching as objective criterion for the pruritus

Studies to evaluate therapies for itching (pruritus) related diseases often require the quantification of the itch sensation. Like all subjective symptoms the evaluation of itching is difficult and can only be done indirectly. With the Pruritometer 2 a measuring system is introduced that evaluates itching by detecting scratching movements. Based on the Pruritometer 1, that processes the signals of a piezoelectric vibration sensor, fixed on the midfinger of the patients dominant hand, and triggers a simple counter, the Pruritometer 2 allows to store the scratch activity during a 24 hours period. For each adjustable time slice of this time period, the amount of scratches and the scratch intensity are recorded. All data can be transferred to a PC via infrared link for further processing with a standard software package. An additional PC-software allows to set various parameters for optimal scratch detection and to test the patient attached system, also via the infrared link. All electronic components are shockproof encapsulated in a milled housing and are attached to a textile watchstrap that is worn by the patient like a wristwatch.

Thermal effects of a combined irrigation method during implant site drilling. A standardized in vitro study using a bovine rib model

OBJECTIVES The purpose of this study was to evaluate the temperature changes during implant osteotomies with a combined irrigation system as compared to the commonly used external and internal irrigation under standardized conditions. MATERIAL AND METHODS Drilling procedures were performed on VII bovine ribs using a computer-aided surgical system that ensured automated intermittent drilling cycles to simulate clinical conditions. A total of 320 drilling osteotomies were performed with twist (2 mm) and conical implant drills (3.5/4.3/5 mm) at various drilling depths (10/16 mm) and with different saline irrigation (50 ml/min) methods (without/external/internal/combined). Temperature changes were recorded in real time by two custom-built thermoprobes with 14 temperature sensors (7 sensors/thermoprobe) at defined measuring depths. RESULTS The highest temperature increase during osteotomies was observed without any coolant irrigation (median, 8.01°C), followed by commonly used external saline irrigation (median, 2.60°C), combined irrigation (median, 1.51°C) and ultimately with internal saline irrigation (median, 1.48°C). Temperature increase with different drill diameters showed significant differences (P < 0.05) regarding drill depth, confirming drill depth and time of drilling as influencing factors of heat generation. Internal saline irrigation showed a significantly smaller temperature increase (P < 0.05) compared with combined and external irrigation. A combined irrigation procedure appears to be preferable (P < 0.05) to an external irrigation method primarily with higher osteotomy depths. CONCLUSIONS Combined irrigation provides sufficient reduction in temperature changes during drilling, and it may be more beneficial in deeper site osteotomies. Further studies to optimize the effects of a combined irrigation are needed.

A newly designed thorax support vest prevents sternum instability after median sternotomy

OBJECTIVE Sternum infection remains one of the primary causes of postoperative morbidity and mortality after median sternotomy. We report the clinical efficacy for primary reinforcement of the sternum with a new design of thorax support vest. METHODS A prospective randomized study including 455 patients was started in September 2007 to evaluate the effectiveness of the Posthorax sternum vest (Epple Inc., Vienna, Austria). One hundred and seventy five patients were treated with the sternum dressing postoperatively (group A), 227 patients did not receive the vest (group B) and 53 patients refused it (group C). Several clinical and operative data were evaluated. All patients were recorded using the STS risk scoring analysis for mediastinitis after cardiac surgery. RESULTS The median age and gender distribution were comparable in both groups. Preoperative data like renal failure, chronic obstructive pulmonary disease, peripheral artery disease, and myocardial infarction were not significant. There were more patients with diabetes in group A and C (A: 39.4%, B: 29.1%, C: 43.4%, p = 0.036). A total of 55.8% underwent coronary bypass grafting, 15.4% aortic valve replacement, 7.7% mitral valve repair and 21.1% concomitant cardiac procedures. The median risk factor analysis and body mass index were comparable. In the follow-up period up to 90 days, in group A we observed 0.6% sternum wound complications, in group B 4.9%, and in group C 9.4% (group A vs B: Fishers exact test p = 0.0152 and group A vs C: p = 0.0029). CONCLUSIONS The use of the Posthorax sternum vest shows a favourable outcome to prevent sternum instability after cardiac surgery. There was one reoperation in patients treated with this sternum vest compared to 16 in the control groups.

Electromyographic Study of the Popliteus Muscle in the Dynamic Stabilization of the Posterolateral Corner Structures of the Knee

Background: The posterolateral corner of the knee consists of static and dynamic stabilizing structures. Knee injuries often include the posterolateral structures. The popliteus muscle-tendon unit is known as the major dynamic stabilizer of the posterolateral corner. Hypothesis: The dynamic stabilization of the posterolateral structures of the knee via the popliteus muscle-tendon unit during a squatting exercise follows a constant activation pattern. Study Design: Controlled laboratory study. Methods: Within the pilot study, 6 volunteers performed 2 exercises to verify the electrode position scheme and to analyze cross-talk. In the main study 2 static exercises (standing and standing with knees flexed 90°) and 2 dynamic exercises (isolated popliteus muscle activation and squats) were recorded in 17 volunteers. Electromyograms were obtained of the popliteus, medial and lateral gastrocnemius, and quadriceps muscles. Knee angle-related muscle activity was recorded. Results: In the pilot study it was assumed that the chosen electrode position allowed selective measurement of popliteus muscle activity. In the main study the mean popliteus onset angle was 43° ± 14° of flexion; activity lasted through the reversal point of the squat to 58° ± 21° of flexion during extension movement. Popliteus activity during all testing cycles revealed that the activity in the standing position is the smallest. The highest activity was recorded during the squat and the popliteus muscle-tendon unit exercise. Conclusion: This study demonstrates an activation pattern of the popliteus muscle-tendon unit with high interindividual differences in the onset angles. A constant activation during the reversal phase of the squatting exercise could be observed. Clinical Relevance: Reconstructive procedures of the posterolateral structures often include reconstruction of the popliteus muscle-tendon unit. Reconstructive procedures are usually done in a static manner, thus not addressing the dynamic stabilizing structure in a true functional way. The findings of the current study may be a useful contribution to the ongoing discussion of this topic.

Pruritometer 1: Portables Meßsystem zur Quantifizierung des Kratzens als objektives Maß für den cholestatischen Pruritus - Pruritometer 1: A Portable Measuring System for the Quantification of Scratching as an Objective Criterion of Cholestatic Pruritus

Objective assessment of subjective symptoms such as pruritus always presents problems, which can often be resolved only indirectly. The objectification of pruritus was necessitated by a study on the efficacy of a serotonin antagonist used as treatment of cholestatic pruritus. In the present paper, a portable measuring system for the indirect objective assessment of pruritus via the quantification of scratching is described. A piezoelectric scratch-vibration sensor for attachment to the middle finger of the patients dominant hand was developed. A sensor interface detects the scratching signals and generates pulses that are then summed in an adapted sports watch. The entire system-Pruritometer 1- is worn by the patient like a wrist watch, and is characterized by ease of handling. Acceptance by the patient is reported to be good. A statistically good correlation between measured (Pruritometer) and visually counted scratches was demonstrated. Pruritometer 2, which will enable scratch frequency and intensity distribution over time to be determined, is presently being developed.

Monitoring of FES-induced muscle activity by continuous EMG-recording.

Functional Electrical Stimulation (FES) requires information on the stimulated muscle for adjustment of the stimulation current, avoidance of muscle fatigue during the conditioning period and long term follow-up. Several applications of chronical FES are in clinical practice, but a system for direct registration of muscle activity under FES still does not exist. In six sheep the right Latissimus Dorsi Muscle (LDM) and Thoracodorsal Nerve were exposed. Stimulation electrodes were applied to each nerve and 3 EMG-applied sensing electrodes were placed into each LDM. The LDM tendon was connected to a force transducer. Burst stimulation was applied and the amplitude was increased from 0 to 4 mA in steps from burst to burst. EMG (M-wave) was amplified and recorded continuously via modified instrumentation amplifier, oscilloscope and tape recorder. Isometric muscle tension was recorded using force transducer, AID interface and PC. Continuous EMG-recording was performed in all cases. Simultaneous recording of muscle tension and EMG revealed a close correlation (lrl=0.95, p < 0.0001) between muscle strength and amplitude of the M-wave. Continuous recording of the EMG seems to be a reliable method for direct monitoring of the stimulated muscle. Three intramuscular electrodes can provide enough information to monitor FES induced muscle activity.

Stress matters! Psychophysiological and emotional loadings of pregnant women undergoing fetal magnetic resonance imaging

BackgroundWhile the application of fetal MRI in high-risk pregnant women is steadily rising, little is known about the psychological consequences of this procedure. The aim of the present study was to investigate emotional and psychophysiological reactions of females undergoing fetal MRI.MethodsSixty women (17–44 ys), assigned for fetal MRI, were included. Affective state was assessed by standardized measures of anxiety, emotional states and depressive symptoms. Stress coping strategies were assessed using a self-report questionnaire. Stress responses were determined using skin conductance levels (SCL) during fetal MRI as well as measurement of salivary cortisol levels immediately before and after fetal MRI.ResultsAnalysis of fast and slow physiological stress measures revealed significant differences between women with and without a supporting person accompanying them to the examination. For SCLs, lower levels of stress during MRI emerged in accompanied women. Women with well-marked stress-coping-strategies experienced lower levels of stress during the examination. Although fast and slow stress measures before and after MRI did not show significant correlations, a significant difference of SCLs pre and post examination was clearly detectable, as well as a trend of decreased cortisol levels for both time points.ConclusionsThe results imply that the elevation of SCLs is an accurate instrument to assess fast stress alterations in patients during fetal MRI. Stress coping strategies and whether women are accompanied or not play an important role in the experience of anxiety and depressive symptoms. These factors should be considered especially in patients with high-risk-pregnancies to improve patient care.