In-Vitro Measurement of Forces During Debridement with a Piezoelectric Ultrasonic Periodontal Scaler.

PURPOSE: This study investigated the magnitude, direction, and temporal aspects of the force applied during instrumentation with a piezoelectric ultrasonic periodontal scaler, compared this force with recommendations in the literature, and assessed the influence of the profession (dentist or dental hygienist) and calculus hardness. MATERIALS AND METHODS: The force applied by ten dental hygienists and six dentists during debridement of comparatively soft and hard artificial dental calculus with a piezoelectric ultrasonic scaler was recorded in-vitro. The total force and its components in three axes were statistically analysed. RESULTS: During debridement of soft artificial dental calculus, the mean total force applied by dental hygienists was 0.34 N (± 0.18 N, range: 0.13 N to 0.59 N) and by dentists 0.28 N (± 0.33 N, range: 0.06 N to 0.95 N), and the total force exceeded 0.5 N approximately 23% and 14% of the time for dental hygienists and dentists, respectively. During debridement of hard artificial dental calculus, the mean total force applied by dental hygienists was 0.63 N (± 0.40 N, range: 0.28 N to 1.64 N) and by dentists 0.57 N (± 0.17 N, range: 0.34 N to 0.76 N); the total force exceeded 0.5 N more than half of the time for both professions. On average, dental hygienists applied 1.85x (p = 0.04) and dentists 2.04x (p = 0.06) higher force on hard than on soft artificial calculus. However, dental hygienists and dentists used similar forces during the debridement of both hard (p = 1.00) and soft (p = 0.26) calculus. CONCLUSION: The force applied during the debridement of hard artificial dental calculus was statistically significantly higher than during the debridement of soft artificial dental calculus. No statistically significant difference between dentists and dental hygienists was found. The force applied by both groups on soft and hard artificial dental calculus frequently exceeded recommended values.

A Direct-Digital 40 µA 100 kb/s Intracardiac Communication Receiver with 250 µs Startup Time for Low Duty-Cycle Leadless Pacemaker Synchronization.

The first commercial dual-chamber leadless pacemaker (LLPM) was introduced recently. The system combines two separate implants situated in the right atrium and the right ventricle of the heart. Implant synchronization is accomplished with conductive intracardiac communication (CIC) using the myocardium and blood as transmission channel. Successful implant synchronization of this dual-chamber LLPM has been demonstrated. However, the continuously active synchronization transceivers, consuming about 800 nA, cause a 25-45% reduction in the projected device longevity. This work proposes an alternative strategy for power-optimized LLPM synchronization, which is based on synchronous duty-cycling of the transceivers and direct-digital CIC (DD-CIC). In line with this strategy, a novel low-power DD-CIC receiver for short-packet communication based on Manchester-encoded data and with fast startup time is presented. The circuit was fabricated in 180 nm CMOS technology and analyzed with respect to sensitivity, current consumption and startup time under highly duty-cycled operation. The receiver achieves a sensitivity of 81.6±7.4 µV at a data rate of 100 kb/s, with an active current consumption of 39.1±0.6 µA and a startup time below 250 µs. Operating the receiver as specified by the proposed LLPM synchronization strategy reduces the current consumption to a measured average value of 73 nA. In conclusion, this work suggests synchronous duty-cycling for CIC-based implant synchronization as a promising concept to severely reduce the current consumption of contemporary dual-chamber LLPMs. Consequently, device longevity may be increased significantly, potentially reducing the frequency of costly and complication-prone re-interventions.

An Evaluation of Parylene Thin Films to Prevent Encrustation for a Urinary Bladder Pressure MEMS Sensor System.

Recent developments in urological implants have focused on preventive strategies to mitigate encrustation and biofilm formation. Parylene, a conformal, pinhole-free polymer coating, has gained attention due to its high biocompatibility and chemical resistance, excellent barrier properties, and low friction coefficient. This study aims to evaluate the effectiveness of parylene C in comparison to a parylene VT4 grade coating in preventing encrustation on a urinary bladder pressure MEMS sensor system. Additionally, silicon oxide (SiOx) applied as a finish coating was investigated for further improvements. An in vitro encrustation system mimicking natural urine flow was used to quantify the formation of urinary stones. These stones were subsequently analyzed using Fourier transform infrared spectrometry (FTIR). Encrustation results were then discussed in relation to coating surface chemical properties. Parylene C and VT4 grades demonstrated a very low encrustation mass, making them attractive options for encrustation prevention. The best performance was achieved after the addition of a hydrophilic SiOx finish coating on parylene VT4 grade. Parylene-based encapsulation proved to be an outstanding solution to prevent encrustation for urological implants.

Development of a Water Transmission Rate (WTR) Measurement System for Implantable Barrier Coatings.

While water vapor transmission rate (WVTR) measurement is standardly used to assess material permeability, a system able to quantify liquid water transmission rate (WTR) measurement is highly desirable for implantable thin film barrier coatings. Indeed, since implantable devices are in contact or immersed in body fluids, liquid WTR was carried out to obtain a more realistic measurement of the barrier performance. Parylene is a well-established polymer which is often the material of choice for biomedical encapsulation applications due to its flexibility, biocompatibility, and attractive barrier properties. Four grades of parylene coatings were tested with a newly developed permeation measurement system based on a quadrupole mass spectrometer (QMS) detection method. Successful measurements of gas and water vapor and the water transmission rates of thin parylene films were performed and validated, comparing the results with a standardized method. In addition, the WTR results allowed for the extraction of an acceleration transmission rate factor from the vapor-to-liquid water measurement mode, which varies from 4 to 4.8 between WVTR and WTR. With a WTR of 72.5 µm g m-2 day-1, parylene C displayed the most effective barrier performance.

Deep-Learning-Based Segmentation of the Shoulder from MRI with Inference Accuracy Prediction.

Three-dimensional (3D)-image-based anatomical analysis of rotator cuff tear patients has been proposed as a way to improve repair prognosis analysis to reduce the incidence of postoperative retear. However, for application in clinics, an efficient and robust method for the segmentation of anatomy from MRI is required. We present the use of a deep learning network for automatic segmentation of the humerus, scapula, and rotator cuff muscles with integrated automatic result verification. Trained on N = 111 and tested on N = 60 diagnostic T1-weighted MRI of 76 rotator cuff tear patients acquired from 19 centers, a nnU-Net segmented the anatomy with an average Dice coefficient of 0.91 ± 0.06. For the automatic identification of inaccurate segmentations during the inference procedure, the nnU-Net framework was adapted to allow for the estimation of label-specific network uncertainty directly from its subnetworks. The average Dice coefficient of segmentation results from the subnetworks identified labels requiring segmentation correction with an average sensitivity of 1.0 and a specificity of 0.94. The presented automatic methods facilitate the use of 3D diagnosis in clinical routine by eliminating the need for time-consuming manual segmentation and slice-by-slice segmentation verification.

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.

Thermal Analysis of Parylene Thin Films for Barrier Layer Applications.

Biocompatible polymer films demonstrating excellent thermal stability are highly desirable for high-temperature (>250 °C) applications, especially in the bioelectronic encapsulation domain. Parylene, as an organic thin film, is a well-established polymer material exhibiting excellent barrier properties and is often the material of choice for biomedical applications. This work investigated the thermal impact on the bulk properties of four types of parylene films: parylene N, C, VT4, and AF4. The films, deposited using the standard Gorham process, were analyzed at varying annealing temperatures from room temperature up to 450 °C. Thermal properties were identified by differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA) methods, while X-ray diffraction (XRD) analysis showed the effect of high-temperature exposure on the structural properties. In addition to thermal and structural analysis, the barrier properties were measured through the helium transmission rate (HTR) and the water vapor transmission rate (WVTR). Fluorinated parylene films were confirmed to be exceptional materials for high-temperature applications. Parylene AF4 film, 25um thick, demonstrated excellent barrier performance after 300 °C exposure, with an HTR and a WVTR of 12.18 × 103 cm3 (STP) m−2 day−1 atm−1 and 6.6 g m−2 day−1, respectively.

Automated quantification of cartilage quality for hip treatment decision support.

PURPOSE: Preservation surgery can halt the progress of joint degradation, preserving the life of the hip; however, outcome depends on the existing cartilage quality. Biochemical analysis of the hip cartilage utilizing MRI sequences such as delayed gadolinium-enhanced MRI of cartilage (dGEMRIC), in addition to morphological analysis, can be used to detect early signs of cartilage degradation. However, a complete, accurate 3D analysis of the cartilage regions and layers is currently not possible due to a lack of diagnostic tools. METHODS: A system for the efficient automatic parametrization of the 3D hip cartilage was developed. 2D U-nets were trained on manually annotated dual-flip angle (DFA) dGEMRIC for femoral head localization and cartilage segmentation. A fully automated cartilage sectioning pipeline for analysis of central and peripheral regions, femoral-acetabular layers, and a variable number of section slices, was developed along with functionality for the automatic calculation of dGEMRIC index, thickness, surface area, and volume. RESULTS: The trained networks locate the femoral head and segment the cartilage with a Dice similarity coefficient of 88 ± 3 and 83 ± 4% on DFA and magnetization-prepared 2 rapid gradient-echo (MP2RAGE) dGEMRIC, respectively. A completely automatic cartilage analysis was performed in 18s, and no significant difference for average dGEMRIC index, volume, surface area, and thickness calculated on manual and automatic segmentation was observed. CONCLUSION: An application for the 3D analysis of hip cartilage was developed for the automated detection of subtle morphological and biochemical signs of cartilage degradation in prognostic studies and clinical diagnosis. The segmentation network achieved a 4-time increase in processing speed without loss of segmentation accuracy on both normal and deformed anatomy, enabling accurate parametrization. Retraining of the networks with the promising MP2RAGE protocol would enable analysis without the need for B1 inhomogeneity correction in the future.

Modulation Scheme Analysis for Low-Power Leadless Pacemaker Synchronization Based on Conductive Intracardiac Communication.

Conductive intracardiac communication (CIC) has been demonstrated as a promising concept for the synchronization of multi-chamber leadless cardiac pacemakers (LLPMs). To meet the 2-5 µW power budget of a LLPM, highly specialized CIC-transceivers, which make optimal use of the cardiac communication channel, need to be developed. However, a detailed investigation of the optimal communication parameters for CIC-based LLPM synchronization is missing so far. This work analyzes the intracardiac communication performance of two low-power modulation techniques, namely On-Off-Keying (OOK) and Manchester-encoded baseband transmission (BB-MAN), as a function of the transmitted bit-energy. The bit error rate (BER) of a prototype dual-chamber LLPM was determined both in simulation and in-vitro experiments on porcine hearts. A BER of 1e -4 was achieved with a median bit-energy in the range of 3-16 pJ (interquartile range: 4-15 pJ) for data rates from 75-500 kbps and a receiver input noise density of 7 nV/ √{Hz}. Both modulation schemes showed comparable performance, with BB-MAN having a slight bit-energy advantage (1-2 dB at 150-500 kbps) under equalized transceiver characteristics. This study demonstrates that reliable CIC-based LLPM synchronization is feasible at transmitted power levels 10 nW under realistic channel conditions and receiver noise performance. Therefore, modulation techniques such, as BB-MAN or OOK, are preferable over recently proposed alternatives, such as pulse position modulation or conductive impulse signaling, since they can be realized with fewer hardware resources and smaller bandwidth requirements. Ultimately, a baseband communication approach might be favored over OOK, due to the more efficient cardiac signal transmission and reduced transceiver complexity.

MRI-based 3D models of the hip joint enables radiation-free computer-assisted planning of periacetabular osteotomy for treatment of hip dysplasia using deep learning for automatic segmentation.

INTRODUCTION: Both Hip Dysplasia(DDH) and Femoro-acetabular-Impingement(FAI) are complex three-dimensional hip pathologies causing hip pain and osteoarthritis in young patients. 3D-MRI-based models were used for radiation-free computer-assisted surgical planning. Automatic segmentation of MRI-based 3D-models are preferred because manual segmentation is time-consuming.To investigate(1) the difference and(2) the correlation for femoral head coverage(FHC) between automatic MR-based and manual CT-based 3D-models and (3) feasibility of preoperative planning in symptomatic patients with hip diseases. METHODS: We performed an IRB-approved comparative, retrospective study of 31 hips(26 symptomatic patients with hip dysplasia or FAI). 3D MRI sequences and CT scans of the hip were acquired. Preoperative MRI included axial-oblique T1 VIBE sequence(0.8 mm3 isovoxel) of the hip joint. Manual segmentation of MRI and CT scans were performed. Automatic segmentation of MRI-based 3D-models was performed using deep learning. RESULTS: (1)The difference between automatic and manual segmentation of MRI-based 3D hip joint models was below 1 mm(proximal femur 0.2 ±â€¯0.1 mm and acetabulum 0.3 ±â€¯0.5 mm). Dice coefficients of the proximal femur and the acetabulum were 98 % and 97 %, respectively. (2)The correlation for total FHC was excellent and significant(r = 0.975, p < 0.001) between automatic MRI-based and manual CT-based 3D-models. Correlation for total FHC (r = 0.979, p < 0.001) between automatic and manual MR-based 3D models was excellent.(3)Preoperative planning and simulation of periacetabular osteotomy was feasible in all patients(100 %) with hip dysplasia or acetabular retroversion. CONCLUSIONS: Automatic segmentation of MRI-based 3D-models using deep learning is as accurate as CT-based 3D-models for patients with hip diseases of childbearing age. This allows radiation-free and patient-specific preoperative simulation and surgical planning of periacetabular osteotomy for patients with DDH.

Intracardiac Turbines Suitable for Catheter-Based Implantation-An Approach to Power Battery and Leadless Cardiac Pacemakers?

OBJECTIVE: Cardiac pacemakers are powered by batteries, which become exhausted after a few years. This is a problem in particular for leadless pacemakers as they are difficult to explant. Thus, autonomous devices powered by energy harvesters are desired. METHODS: We developed an energy harvester for endocardial implantation. The device contains a microgenerator to convert a flexible turbine runner's rotation into electrical energy. The turbine runner is driven by the intracardiac blood flow; a magnetic coupling allows hermetical sealing. The energy harvester has a volume of 0.34 cm3 and a weight of 1.3 g. Computational simulations were performed to assess the hemodynamic impact of the implant. The device was studied on a mock circulation and an in vivo trial was performed in a domestic pig. RESULTS: In this article, we show that an energy harvester with a 2-bladed 14-mm-diameter turbine runner delivers 10.2 ± 4.8 µW under realistic conditions (heart rate 80/min, stroke volume 75 ml) on the bench. An increased output power (>80 µW) and power density (237.1 µW/cm3) can be achieved by higher stroke volumes, increased heart rates, or larger turbine runners. The device was successfully implanted in vivo. CONCLUSION: The device is the first flow-based energy harvester suitable for catheter-based implantation and provides enough energy to power a leadless pacemaker. SIGNIFICANCE: The high power density, the small volume, and the flexible turbine runner blades facilitate the integration of the energy harvester in a pacemaker. This would allow overcoming the need for batteries in leadless pacemakers.

Protein Microarray Copying: Easy on-Demand Protein Microarray Generation Compatible with Fluorescence and Label-Free Real-Time Analysis.

Protein microarrays are essential to understand complex protein interaction networks. Their production, however, is a challenge and renders this technology unattractive for many laboratories. Recent developments in cell-free protein microarray generation offer new opportunities, but are still expensive and cumbersome in practice. Herein, we describe a cost-effective and user-friendly method for the cell-free production of protein microarrays. From a polydimethylsiloxane (PDMS) flow cell containing an expressible DNA microarray, proteins of interest are synthesised by cell-free expression and then immobilised on a capture surface. The resulting protein microarray can be regarded as a "copy" of the DNA microarray. 2 His6 - and Halo-tagged fluorescent reference proteins were used to demonstrate the functionality of nickel nitrilotriacetic acid (Ni-NTA) and Halo-bind surfaces in this copy system. The described process can be repeated several times on the same DNA microarray. The identity and functionality of the proteins were proven during the copy process by their fluorescence and on the surface through a fluorescent immune assay. Also, single-colour reflectometry (SCORE) was applied to show that, on such copied arrays, real-time binding kinetic measurements were possible.

Development and in-vitro characterization of an implantable flow sensing transducer for hydrocephalus.

An implantable transducer for monitoring the flow of Cerebrospinal fluid (CSF) for the treatment of hydrocephalus has been developed which is based on measuring the heat dissipation of a local thermal source. The transducer uses passive telemetry at 13.56 MHz for power supply and read out of the measured flow rate. The in vitro performance of the transducer has been characterized using artificial Cerebrospinal Fluid (CSF) with increased protein concentration and artificial CSF with 10% fresh blood. After fresh blood was added to the artificial CSF a reduction of flow rate has been observed in case that the sensitive surface of the flow sensor is close to the sedimented erythrocytes. An increase of flow rate has been observed in case that the sensitive surface is in contact with the remaining plasma/artificial CSF mix above the sediment which can be explained by an asymmetric flow profile caused by the sedimentation of erythrocytes having increased viscosity compared to artificial CSF. After removal of blood from artificial CSF, no drift could be observed in the transducer measurement which could be associated to a deposition of proteins at the sensitive surface walls of the packaged flow transducer. The flow sensor specification requirement of +-10% for a flow range between 2 ml/h and 40 ml/h. could be confirmed at test conditions of 37 degrees C.

Minimally invasive intraoperative stiffness measurement of lumbar spinal motion segments.

OBJECTIVE: To test a new tiny-tipped intraoperative diagnostic tool that was designed to provide the surgeon with reliable stiffness data on the motion segment during microdiscectomy. A decrease in stiffness after nuclectomy and a measurable influence of muscle tension were assumed. If the influence of muscle tension on the motion segment could at least be ruled out, there should be no difference with regard to stiffness between women and men. If these criteria are met, this new intraoperative diagnostic tool could be used in further studies for objective decision-making regarding additional stabilization systems after microdiscectomy. METHODS: After evaluation of the influence of muscle relaxation during in vivo measurements with a spinal spreader between the spinous processes, 21 motion segments were investigated in 21 patients. Using a standardized protocol, including quantified muscle relaxation, spinal stiffness was measured before laminotomy and after nuclectomy. RESULTS: The decrease in stiffness after microdiscectomy was highly significant. There were no statistically significant differences between men and women. The average stiffness value before discectomy was 33.7 N/mm, and it decreased to 25.6 N/mm after discectomy. The average decrease in stiffness was 8.1 N/mm (24%). CONCLUSION: In the moderately degenerated spine, stiffness decreases significantly after microdiscectomy. Control for muscle relaxation is essential when measuring in vivo spinal stiffness. The new spinal spreader was found to provide reliable data. This spreader could be used in further studies for objective decision-making about additional stabilization systems after microdiscectomy.

Oxygen and glucose distribution after intracorneal lens implantation.

PURPOSE: Insertion of an implant in the cornea to achieve corneal multifocality has been suggested as a solution for presbyopia. However, unresolved issues related to nutrient transport need to be resolved. Our aim was to find the best lens position and influence lens transport properties in order to optimize nutrient supply to corneal cells. METHOD: An axisymmetric corneal model was built to simulate the nutrient transport in the cornea. Oxygen and glucose concentrations were calculated for normal cornea and intracorneal lens wearing conditions. The simulation considers the different tissue layers (epithelium, stroma, and endothelium) as well as layer and solute concentration dependent consumption. RESULTS: The minimum oxygen tension in the cornea was found to be higher when the lens was placed at 3/4 of the corneal thickness. Moreover, in this position, the influence of the inlay diffusivity was smaller than at more anterior or posterior placements. The diffusivity of the inlay affects the way nutrients will be transported through the cornea. The threshold where glucose may diffuse through or around the implant was found to be 1/100th of the stromal diffusivity. CONCLUSIONS: Computational methods are especially attractive to study nutrient transport in the cornea due to the difficulties associated with in vivo or in vitro measurements. The exact parameters that dictate the corneal metabolism are not known. However, the combined analysis of oxygen and glucose distribution is valuable in order to predict the complex physiological changes that arise under intracorneal lens implantation.

Safety of active implantable devices during MRI examinations: a finite element analysis of an implantable pump.

The goal of this study was to propose a general numerical analysis methodology to evaluate the magnetic resonance imaging (MRI)-safety of active implants. Numerical models based on the finite element (FE) technique were used to estimate if the normal operation of an active device was altered during MRI imaging. An active implanted pump was chosen to illustrate the method. A set of controlled experiments were proposed and performed to validate the numerical model. The calculated induced voltages in the important electronic components of the device showed dependence with the MRI field strength. For the MRI radiofrequency fields, significant induced voltages of up to 20 V were calculated for a 0.3T field-strength MRI. For the 1.5 and 3.0OT MRIs, the calculated voltages were insignificant. On the other hand, induced voltages up to 11 V were calculated in the critical electronic components for the 3.0T MRI due to the gradient fields. Values obtained in this work reflect to the worst case situation which is virtually impossible to achieve in normal scanning situations. Since the calculated voltages may be removed by appropriate protection circuits, no critical problems affecting the normal operation of the pump were identified. This study showed that the proposed methodology helps the identification of the possible incompatibilities between active implants and MR imaging, and can be used to aid the design of critical electronic systems to ensure MRI-safety.