Development and evaluation of a titanium-based planar ultrasonic scalpel for precision surgery.

This paper introduces a titanium-based planar ultrasonic microscalpel. The concept of silicon-based planar ultrasonic transducers has already been proven, but they are not yet suitable for clinical use due to material failure. The main objective of this work was to develop a smaller, lighter, and more cost-effective ultrasonic scalpel that could be used as an alternative or supplementary device to current surgical instruments. Various prototypes were fabricated and characterized, differing in bonding by three epoxy adhesives and two solder pastes as well as three variations in tip design. The instruments were designed to operate in the frequency range of commercial instruments and to generate a longitudinal displacement amplitude. The electro-mechanical characterization through impedance analysis and vibration measurements was complemented by an in vitro cutting trial and an acute in vivo animal experiment in comparison to commercial ultrasonic and electrosurgical devices. The operating frequency was around 40 kHz and 48 kHz depending on whether matched or unmatched operation was used. Unmatched operation turned out to be more suitable, achieving displacement amplitudes of 25.3 μm and associated velocity amplitudes of up to 7.9 m/s at an electrical power of 10.2 W. The cutting ability was demonstrated in vivo by successful dissection even under anticoagulation. The geometry of the instrument tip was found to have a major influence on cutting performance by affecting the resonance behaviour and tissue penetration

Potential of subdermal solar energy harvesting for medical device applications based on worldwide meteorological data.

SIGNIFICANCE Active implants require batteries as power supply. Their lifetime is limited and may require a second surgical intervention for replacement. Intracorporal energy harvesting techniques generate power within the body and supply the implant. Solar cells below the skin can be used to harvest energy from light. AIM To investigate the potential of subdermal solar energy harvesting. APPROACH We evaluated global radiation data for defined time slots and calculated the output power of a subdermal solar module based on skin and solar cell characteristics. We assumed solar exposure profiles based on daily habits for an implanted solar cell. The output power was calculated for skin types VI and I/II. RESULTS We show that the yearly mean power in most locations on Earth is sufficient to power modern cardiac pacemakers if 10 min midday solar irradiation is assumed. All skin types are suitable for solar harvesting. Moreover, we provide a software tool to predict patient-specific output power. CONCLUSIONS Subdermal solar energy harvesting is a viable alternative to primary batteries. The comparison to a human case study showed a good agreement of the results. The developed code is available open source to enable researchers to investigate further applications of subdermal solar harvesting

Mechanical testing and comparison of porcine tissue, silicones and 3D-printed materials for cardiovascular phantoms

Background: Cardiovascular phantoms for patient education, pre-operative planning, surgical training, haemodynamic simulation, and device testing may help improve patient care. However, currently used materials may have different mechanical properties compared to biological tissue.Methods/Aim: The aim of this study was to investigate the mechanical properties of 3D-printing and silicone materials in comparison to biological cardiovascular tissues. Uniaxial cyclic tension testing was performed using dumbbell samples from porcine tissue (aorta, pulmonary artery, right and left ventricle). Flexible testing materials included 15 silicone (mixtures) and three 3D-printing materials. The modulus of elasticity was calculated for different deformation ranges.Results: The modulus of elasticity (0%–60%) for the aorta ranged from 0.16 to 0.18 N/mm2, for the pulmonary artery from 0.07 to 0.09 N/mm2, and for the right ventricle as well as the left ventricle short-axis from 0.1 to 0.16 N/mm2. For silicones the range of modulus of elasticity was 0.02–1.16 N/mm2, and for the 3D-printed materials from 0.85 to 1.02 N/mm2. The stress-strain curves of all tissues showed a non-linear behaviour in the cyclic tensile testing, with a distinct toe region, followed by exponential strain hardening behaviour towards the peak elongation. The vessel samples showed a more linear behaviour comparted to myocardial samples. The silicones and 3D printing materials exhibited near-linearity at higher strain ranges, with a decrease in stiffness following the initial deformation. All samples showed a deviation between the loading and unloading curves (hysteresis), and a reduction in peak force over the first few cycles (adaptation effect) at constant deformation.Conclusion: The modulus of elasticity of silicone mixtures is more in agreement to porcine cardiovascular tissues than 3D-printed materials. All synthetic materials showed an almost linear behaviour in the mechanical testing compared to the non-linear behaviour of the biological tissues, probably due to fibre recruitment mechanism in the latter

Inverse Finite Element Approach to Identify the Post-Necking Hardening Behavior of Polyamide 12 under Uniaxial Tension.

Finite-element (FE) simulations that go beyond the linear elastic limit of materials can aid the development of polymeric products such as stretch blow molded angioplasty balloons. The FE model requires the input of an appropriate elastoplastic material model. Up to the onset of necking, the identification of the hardening curve is well established. Subsequently, additional information such as the cross-section and the triaxial stress state inside the specimen is required. The present study aims to inversely identify the post-necking hardening behavior of the semi-crystalline polymer polyamide 12 (PA12) at different temperatures. Our approach uses structural FE simulations of a dog-bone tensile specimen in LS-DYNA with mesh sizes of 1 mm and 2 mm, respectively. The FE simulations are coupled with an optimization routine defined in LS-OPT to identify material properties matching the experimental behavior. A Von Mises yield criterion coupled with a user-defined hardening curve (HC) were considered. Up to the beginning of necking, the Hockett-Sherby hardening law achieved the best fit to the experimental HC. To fit the entire HC until fracture, an extension of the Hockett-Sherby law with power-law functions achieved an excellent fit. Comparing the simulation and the experiment, the following coefficient of determination R2 could be achieved: Group I: R2 > 0.9743; Group II: R2 > 0.9653; Group III: R2 > 0.9927. Using an inverse approach, we were able to determine the deformation behavior of PA12 under uniaxial tension for different temperatures and mathematically describe the HC

Feasibility of transesophageal phrenic nerve stimulation

Background Every year, more than 2.5 million critically ill patients in the ICU are dependent on mechanical ventilation. The positive pressure in the lungs generated by the ventilator keeps the diaphragm passive, which can lead to a loss of myofibers within a short time. To prevent ventilator-induced diaphragmatic dysfunction (VIDD), phrenic nerve stimulation may be used. Objective The goal of this study is to show the feasibility of transesophageal phrenic nerve stimulation (TEPNS). We hypothesize that selective phrenic nerve stimulation can efficiently activate the diaphragm with reduced co-stimulations. Methods An in vitro study in saline solution combined with anatomical findings was performed to investigate relevant stimulation parameters such as inter-electrode spacing, range to target site, or omnidirectional vs. sectioned electrodes. Subsequently, dedicated esophageal electrodes were inserted into a pig and single stimulation pulses were delivered simultaneously with mechanical ventilation. Various stimulation sites and response parameters such as transdiaphragmatic pressure or airway flow were analyzed to establish an appropriate stimulation setting. Results Phrenic nerve stimulation with esophageal electrodes has been demonstrated. With a current amplitude of 40 mA, similar response figures of the diaphragm activation as compared to conventional stimulation with needle electrodes at 10mA were observed. Directed electrodes best aligned with the phrenic nerve resulted in up to 16.9 % higher amplitude at the target site in vitro and up to 6 cmH20 higher transdiaphragmatic pressure in vivo as compared to omnidirectional electrodes. The activation efficiency was more sensitive to the stimulation level inside the esophagus than to the inter-electrode spacing. Most effective and selective stimulation was achieved at the level of rib 1 using sectioned electrodes 40 mm apart. Conclusion Directed transesophageal phrenic nerve stimulation with single stimuli enabled diaphragm activation. In the future, this method might keep the diaphragm active during, and even support, artificial ventilation. Meanwhile, dedicated sectioned electrodes could be integrated into gastric feeding tubes

A Surface-Integrated Sensor Network for Personalized Multifunctional Catheters*

Augmenting the sensing/actuating capabilities of multifunctional catheters used for minimally invasive interventions has been fostered by the reduction of transducers’ sizes. However, increasing the number of transducers to benefit from the entire catheter surface is challenging due to the number of connections and/or the required integrated circuits dedicated for multiplexing the transducer signals. Modular concepts enabling personalized catheters are lacking, at all. In this work, we investigated the feasibility of a simple and daisy-chainable transducer node network for active catheters, which overcomes these limitations. Sequentially accessible nodes enabling analog interaction (including signal buffering) with transducers were designed and fabricated using miniature components suited for catheter integration. The effective sampling rate (ESR) per node for acquiring bio-signals from 10 nodes was examined for various signal-to-noise ratios. Thanks to the low circuit complexity, an ESR up to 20 kHz was achieved, which is high enough for many bio-signals.Clinical relevance— Typical daisy-chaining features, namely theoretically indefinite node extension and simple reconfiguration facilitates modularization of the catheter design. The proposed network consequently ensures application and patient-specific requirements while incorporating transducer functions over the entire catheter surface, both may improve minimally invasive interventions

High-resolution esophageal long-term ECG allows detailed atrial wave morphology analysis in case of atrial ectopic beats

Detection of arrhythmic atrial beats in surface ECGs can be challenging when they are masked by the R or T wave, or do not affect the RR-interval. Here, we present a solution using a high-resolution esophageal long-term ECG that offers a detailed view on the atrial electrical activity. The recorded ECG shows atrial ectopic beats with long coupling intervals, which can only be successfully classified using additional morphology criteria. Esophageal high-resolution ECGs provide this information, whereas surface long-term ECGs show poor atrial signal quality. This new method is a promising tool for the long-term rhythm monitoring with software-based automatic classification of atrial beat

Respiratory rate estimation from multi-channel signals using auto-regulated adaptive extended Kalman filter

Background: Respiration rate (RR) is a major cause for false alarms in intensive care units (ICU) and is primarily impaired by the artifact prone signals from skin-attached electrodes. Catheter-integrated esophageal electrodes are an alternative source for multi-channel physiological signals from multiple organs such as the heart and the diaphragm. Nonlinear estimation and sensor fusion are promising techniques for extracting the respiratory activity from such multi-component signals, however, pathologic breathing patterns with rapid RR changes typically observed in patient populations such as premature infants, pose significant challenges. Methods: We developed an auto-regulated adaptive extended Kalman filter (AA-EKF), which iteratively adapts the system model and the noise parameters based on the respiratory pattern. AA-EKF was tested on neonatal esophageal observations (NEO), and also on simulated multi-components signals created using waveforms in CapnoBase and ETNA databases. Results: AA-EKF derived RR (RRAA-EKF) from NEO had lower median (inter-quartile range) error of 0.1 (10.6) breaths per minute (bpm) compared to contemporary neonatal ICU monitors (RRNICU): −3.8 (15.7) bpm (p <0.001). RRAA-EKF error of −0.2 (3.2) bpm was achieved for ETNA wave forms and a bias (95% LOA) of 0.1 (−5.6, 5.9) in breath count. Mean absolute error (MAE) of RRAA-EKF with Capnobase waveforms, as median (inter-quartile range), at 0.3 (0.2) bpm was comparable to the literature reported values. Discussion: The auto-regulated approach allows RR estimation on a broad set of clinical data without requiring extensive patient specific adjustments. Causality and fast response times of EKF based algorithms makes the AA-EKF suitable for bedside monitoring in the ICU setting