QDOT MICRO™ versus THERMOCOOL® SMARTTOUCH™ and THERMOCOOL SMARTTOUCH® Surround Flow in radiofrequency ablation of paroxysmal atrial fibrillation.

Aim: The objective of this study was to indirectly compare QDOT MICRO™ (QDOT), Thermocool® SmartTouch™ (ST) and Thermocool® SmartTouch® Surround Flow (STSF) to treat paroxysmal atrial fibrillation. Methods: Differences in baseline characteristics between study cohorts were reduced by reweighting patients using inverse probability of treatment weighting. The primary outcome was procedure time. Secondary outcomes were fluoroscopy time, clinical success at 12 months, and rhythm monitoring-adjusted recurrence. Results: QDOT was associated with significantly faster mean procedure and fluoroscopy time, and significant improvement in the rate of recurrence compared with pooled ST/STSF. No difference was observed for clinical success at 12 months. Conclusion: QDOT was associated with greater efficiency, greater effectiveness in rhythm monitoring-adjusted recurrence and similar effectiveness in clinical success at 12 months compared with pooled ST/STSF.

Impact of cooling on shaping ability of thermally treated files in canal models with double curvature.

Background: This study compared the ability of thermally treated files in shaping simulated canals with double curvature. Fifty-six canals were enlarged to a final size of 25 with ProTaper Next (PTN) or ZenFlex (ZF). Materials: Half of the samples were shaped with cooled files (n = 14 each). The amount of removed resin was measured and canal deviation was determined at eight levels. Shaping time and maximum shaping torque values were also recorded. Data were statistically analyzed using analysis of variance and LSD, Kruskal-Wallis, and chi-square tests at a 0.05 significance level. Results: Compared to PTN and cooled PTN, ZF and cooled ZF required lesser time to shape the canals. The maximum torques were found comparable between the groups. All the groups generated negligible deviations at every canal level evaluated and maintained the canal geometry. Although not significant, the cooled PTN and ZF files exhibited lesser canal deviations than their counterparts. Conclusion: All groups demonstrated similar shaping ability whilst maintaining the original curvature of the canal in simulated canals with double curvature. However, ZF groups were able to shape the canals faster than PTN groups. There was a trend that cooled files made lesser canal deviations compared to their counterparts.

A Novel Soft Glove Utilizing Honeycomb Pneumatic Actuators (HPAs) for Assisting Activities of Daily Living.

Fabric-based pneumatic actuators (FPAs) are extensively employed in the design of lightweight and compliant soft wearable assistive gloves. However, conventional FPAs typically exhibit limited output force, thereby restricting the applications of such gloves. This paper presents the development of a novel honeycomb pneumatic actuator (HPA) constructed using flexible thermoplastic polyurethane (TPU) coating through hot pressing or ultrasonic welding techniques. Compared to the previously utilized double-layer fabric-based pneumatic actuators (DLFPAs), the HPAs yields a remarkable 862% increase in end output force. It can produce a tip force of 13.57 N at a pressure of 150 kPa. The integration of HPAs onto a soft pneumatic glove enables the facilitation of various activities of daily living. A series of trials involving nine patients were conducted to assess the effectiveness of the soft glove. The experimental results indicate that when assisted by the glove, the patients' finger metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints achieved angles of 87.67 ± 19.27° and 64.2 ± 30.66°, respectively. Additionally, the average fingertip force reached 10.16 ± 4.24 N, the average grip force reached 26.04 ± 15.08 N, and the completion rate of daily functions for the patients increased from 39% to 76%. These outcomes demonstrate that the soft glove effectively aids in finger movements and significantly enhances the patients' daily functioning.

Toward a novel soft robotic system for minimally invasive interventions.

PURPOSE: During minimally invasive surgery, surgeons maneuver tools through complex anatomies, which is difficult without the ability to control the position of the tools inside the body. A potential solution for a substantial portion of these procedures is the efficient design and control of a pneumatically actuated soft robot system. METHODS: We designed and evaluated a system to control a steerable catheter tip. A macroscale 3D printed catheter tip was designed to have two separately pressurized channels to induce bending in two directions. A motorized hand controller was developed to allow users to control the bending angle while manually inserting the steerable tip. Preliminary characterization of two catheter tip prototypes was performed and used to map desired angle inputs into pressure commands. RESULTS: The integrated robotic system allowed both a novice and a skilled surgeon to position the steerable catheter tip at the location of cylindrical targets with sub-millimeter accuracy. The novice was able to reach each target within ten seconds and the skilled surgeon within five seconds on average. CONCLUSION: This soft robotic system enables its user to simultaneously insert and bend the pneumatically actuated catheter tip with high accuracy and in a short amount of time. These results show promise concerning the development of a soft robotic system that can improve outcomes in minimally invasive interventions.

Eddy currents analysis methods for an MRI longitudinal gradient coil.

PURPOSE: The rapid switching of the gradient fields induces eddy currents in neighboring metallic structures, causing undesirable effects. Numerical computations are thus required to understand eddy-currents effects for designing/implementing mitigation (involving passive shielding) and compensating techniques (using pre-emphasis). Previously, the network-analysis (NA) method was introduced to compute z-gradient eddy currents, although limited to a circularly symmetric and unconnected coil. Multi-layer integral method (MIM) method was recently introduced, modifying the circuit equation involving stream functions. We tailor MIM (TMIM) for a more general eddy-currents analysis in thin structures. Z-gradient eddy currents are analyzed and then compared using three methods (NA, TMIM, and Ansys). The analysis helps to evaluate the efficiency of passive shielding and to compensate eddy currents. METHODS: NA and TMIM computational frameworks for harmonic and transient eddy-currents analysis were implemented and cross-validated against Ansys Maxwell. A pre-emphasis pulse was modeled for compensating eddy currents. RESULTS: Eddy-currents analysis of an unconnected z-gradient coil in both the passive shield and cryostat were computed, and results were comparable to the least computationally efficient Ansys simulations. Although NA computations are fast, TMIM is implemented with reasonable efficiency and applied to circularly unsymmetric geometries. TMIM computations were further validated against Ansys using a connected z-gradient. Our computations allowed the effective evaluation of the performance of three various passive-shielding configurations, non-capped, capped, and slitted (for the first time), and an effective pre-emphasis compensation model was computed. CONCLUSION: Three eddy-currents analysis methods were studied and compared. Computationally efficient TMIM allows both harmonic and transient eddy-currents analysis involving different/complex gradient configurations/situations as well as involved shielding structures. Eddy-currents pre-emphasis compensation was demonstrated.

Microfluidic Bioreactor with Fibrous Micromixers for In Vitro mRNA Transcription.

A new type of microfluidic bioreactor with fibrous micromixers for the ingredient mixing and a long macrochannel for the in vitro transcription reaction was fabricated for the continuous production of mRNA. The diameter of the fibrous microchannels in the micromixers was tuned by using an electrospun microfibrous disc with different microfiber diameters. The micromixer with a larger diameter of fibrous microchannels exhibited a better mixing performance than the others. The mixing efficiency was increased to 0.95 while the mixture was passed through the micromixers, suggesting complete mixing. To demonstrate the continuous production of mRNA, the ingredients for in vitro transcription were introduced into the perfluoropolyether microfluidic bioreactor. The mRNA synthesized by the microfluidic bioreactor had the same sequence and in vitro/in vivo performances as those prepared by the bulk reaction. The continuous reaction in the microfluidic bioreactor with efficient mixing performance can be used as a powerful platform for various microfluidic reactions.

Thermal safety considerations for implantable micro-coil design.

Micro magnetic stimulation of the brain via implantable micro-coils is a promising novel technology for neuromodulation. Careful consideration of the thermodynamic profile of such devices is necessary for effective and safe designs.Objective.We seek to quantify the thermal profile of bent wire micro-coils in order to understand and mitigate thermal impacts of micro-coil stimulation.Approach. In this study, we use fine wire thermocouples and COMSOL finite element modeling to examine the profile of the thermal gradients generated near bent wire micro-coils submerged in a water bath during stimulation. We tested a range of stimulation parameters previously reported in the literature such as voltage amplitude, stimulus frequency, stimulus repetition rate and coil wire materials.Main results. We found temperature increases ranging from <1 °C to 8.4 °C depending upon the stimulation parameters tested and coil wire materials used. Numerical modeling of the thermodynamics identified hot spots of the highest temperatures along the micro-coil contributing to the thermal gradients and demonstrated that these thermal gradients can be mitigated by the choice of wire conductor material and construction geometry.Significance. ISO standard 14708-1 designates a thermal safety limit of 2 °C temperature increase for active implantable medical devices. By switching the coil wire material from platinum/iridium to gold, our study achieved a 5-6-fold decrease in the thermal impact of coil stimulation. The thermal gradients generated from the gold wire coil were measured below the 2 °C safety limit for all stimulation parameters tested.

Preclinical cardiac perforation reduction in leadless pacing: An update to the Micra leadless pacemaker delivery system.

BACKGROUND: Leadless pacemakers have been developed to avoid some of the complications that are associated transvenous pacemakers. Pericardial effusion is a rare complication of leadless pacemaker implantation, which may result from perforation of the delivery catheter. In this study, we describe preclinical perforation performance of an updated Micra delivery catheter. METHODS: To assess preclinical perforation performance of the updated delivery catheter, three analyses were performed. First, Finite Element Analysis (FEA) computational modeling was performed to estimate the target tissue stress during Micra delivery catheter tenting. Second, benchtop perforation forces of ovine tissue were recorded for the original and updated delivery catheters. Finally, a Monte-Carlo simulation combining human cadaveric Micra implant forces and human ventricular tissue perforation properties was performed to estimate clinical perforation performance. RESULTS: FEA modeling demonstrated a 66% reduction in target tissue stress when using the updated Micra delivery catheter (6.2 vs. 2.2 psi, Original vs. Updated Micra delivery catheter). Updated Micra delivery catheters required 20% more force to perforate porcine ventricular tissues in benchtop testing (µupd  = 26.9N vs. µorg  = 22.4N, p = .01). Monte-Carlo Simulation of catheter performance in human cadaveric tissues predicts 28.5% reduction of catheter-perforated cases with the updated delivery catheter. CONCLUSIONS: This study, using computer modelling and benchtop experimentation, has indicated that increased surface area and rounding of the updated Micra catheter tip significantly improves preclinical perforation performance. It will be important to evaluate the impact of these catheter design changes with robust registry data.

Cardiac pacing and lead devices management: 25 years of research at EP Europace journal.

AIMS: Cardiac pacing represents a key element in the field of electrophysiology and the treatment of conduction diseases. Since the first issue published in 1999, EP Europace has significantly contributed to the development and dissemination of the research in this area. METHODS: In the last 25 years, there has been a continuous improvement of technologies and a great expansion of clinical indications making the field of cardiac pacing a fertile ground for research still today. Pacemaker technology has rapidly evolved, from the first external devices with limited longevity, passing through conventional transvenous pacemakers to leadless devices. Constant innovations in pacemaker size, longevity, pacing mode, algorithms, and remote monitoring highlight that the fascinating and exciting journey of cardiac pacing is not over yet. CONCLUSION: The aim of the present review is to provide the current 'state of the art' on cardiac pacing highlighting the most important contributions from the Journal in the field.

Participatory Action Design and Engineering of Powered Personal Transfer System for Wheelchair Users: Initial Design and Assessment.

Caregivers that assist with wheelchair transfers are susceptible to back pain and occupational injuries. The study describes a prototype of the powered personal transfer system (PPTS) consisting of a novel powered hospital bed and a customized Medicare Group 2 electric powered wheelchair (EPW) working together to provide a no-lift solution for transfers. The study follows a participatory action design and engineering (PADE) process and describes the design, kinematics, and control system of the PPTS and end-users' perception to provide qualitative guidance and feedback about the PPTS. Thirty-six participants (wheelchair users (n = 18) and caregivers (n = 18)) included in the focus groups reported an overall positive impression of the system. Caregivers reported that the PPTS would reduce the risk of injuries and make transfers easier. Feedback revealed limitations and unmet needs of mobility device users, including a lack of power seat functions in the Group-2 wheelchair, a need for no-caregiver assistance/capability for independent transfers, and a need for a more ergonomic touchscreen. These limitations may be mitigated with design modifications in future prototypes. The PPTS is a promising robotic transfer system that may aid in the higher independence of powered wheelchair users and provide a safer solution for transfers.

Portable manipulation system for commercial robotic surgery forceps.

BACKGROUND: Transition from the utilisation of traditional instruments to new robotic methodologies in surgical operations occurs rapidly. Although the implementation of these methodologies to classical surgery operations is advantageous due to increased precisions and enhanced motion capabilities of robotic systems, overall worldwide accessibility and adaptation are still limited due to high equipment costs and special infrastructure requirements. METHODOLOGY: The design of four degrees of freedom low cost, compact and portable manipulation system was proposed to allow the utilisation of commercial robotic surgery forceps like a conventional laparoscopy instrument without the necessity of bulky manipulation systems. RESULTS: The structural design of the system was carried out along with necessary kinematic and coupled motion analysis. Prototypes were constructed. Hardware verification of the system was executed using implemented control methodology. CONCLUSIONS: The proposed design successfully demonstrated the advantages of multi degree of freedom robotic surgery forceps in a portable handheld system compared to classical laparoscopy instruments.

A comparative study of the two leadless pacemakers in clinical practice.

INTRODUCTION: AVEIR-VR leadless pacemaker (LP) was recently approved for clinical use. Although trial data were promising, post-approval real world data with regard to its effectiveness and safety is lacking. To report our early experience with AVEIR-VR LP with regard to its effectiveness and safety and compare it with MICRA-VR. METHODS: The first 25 patients to undergo AVEIR-VR implant at our institution between June and November 2022, were compared to 25 age- and sex-matched patients who received MICRA-VR implants. RESULTS: In both groups, mean age was 73 years and 48% were women. LP implant was successful in 100% of patients in both groups. Single attempt deployment was achieved in 80% of AVEIR-VR and 60% of MICRA-VR recipients (p = 0.07). Fluoroscopy, implant, and procedure times were numerically longer in the AVEIR-VR group compared to MICRA-VR group (p > 0.05). No significant periprocedural complications were noted in both groups. Incidence of ventricular arrhythmias were higher in the AVEIR-VR group (20%) compared to the MICRA-VR group (0%) (p = 0.043). At 2 and 8 weeks follow-up, device parameters remained stable in both groups with no device dislodgements. The estimated battery life at 8 weeks was significantly longer in the AVEIR-VR group (15 years) compared to the MICRA-VR group (8 years) (p = 0.047). With 3-4 AVEIR-VR implants, the learning curve for successful implantation reached a steady state. CONCLUSION: Our initial experience with AVEIR-VR show that it has comparable effectiveness and safety to MICRA-VR. Larger sample studies are needed to confirm our findings.

Impact of gas humidification and nebulizer position under invasive ventilation: preclinical comparative study of regional aerosol deposition.

Successful aerosol therapy in mechanically ventilated patients depends on multiple factors. Among these, position of nebulizer in ventilator circuit and humidification of inhaled gases can strongly influence the amount of drug deposited in airways. Indeed, the main objective was to preclinically evaluate impact of gas humidification and nebulizer position during invasive mechanical ventilation on whole lung and regional aerosol deposition and losses. Ex vivo porcine respiratory tracts were ventilated in controlled volumetric mode. Two conditions of relative humidity and temperature of inhaled gases were investigated. For each condition, four different positions of vibrating mesh nebulizer were studied: (i) next to the ventilator, (ii) right before humidifier, (iii) 15 cm to the Y-piece adapter and (iv) right after the Y-piece. Aerosol size distribution were calculated using cascade impactor. Nebulized dose, lung regional deposition and losses were assessed by scintigraphy using 99mtechnetium-labeled diethylene-triamine-penta-acetic acid. Mean nebulized dose was 95% ± 6%. For dry conditions, the mean respiratory tract deposited fractions reached 18% (± 4%) next to ventilator and 53% (± 4%) for proximal position. For humidified conditions, it reached 25% (± 3%) prior humidifier, 57% (± 8%) before Y-piece and 43% (± 11%) after this latter. Optimal nebulizer position is proximal before the Y-piece adapter showing a more than two-fold higher lung dose than positions next to the ventilator. Dry conditions are more likely to cause peripheral deposition of aerosols in the lungs. But gas humidification appears hard to interrupt efficiently and safely in clinical use. Considering the impact of optimized positioning, this study argues to maintain humidification.

A cell-electrode interface signal-to-noise ratio model for 3D micro-nano electrode.

Objective. Three-dimensional micro-nano electrodes (MNEs) with the vertical nanopillar array distributed on the surface play an increasingly important role in neural science research. The geometric parameters of the nanopillar array and the cell adhesion state on the nanopillar array are the factors that may affect the MNE recording. However, the quantified relationship between these parameters and the signal-to-noise ratio (SNR) is still unclear. This paper establishes a cell-MNE interface SNR model and obtains the mathematical relationship between the above parameters and SNR.Approach. The equivalent electrical circuit and numerical simulation are used to study the sensing performance of the cell-electrode interface. The adhesion state of cells on MNE is quantified as engulfment percentage, and an equivalent cleft width is proposed to describe the signal loss caused by clefts between the cell membrane and the electrode surface.Main results. Whether the planar substrate is insulated or not, the SNR of MNE is greater than planar microelectrode only when the engulfment percentage is greater than a certain value. Under the premise of maximum engulfment percentage, the spacing and height of nanopillars should be minimized, and the radius of the nanopillar should be maximized for better signal quality.Significance. The model can clarify the mechanism of improving SNR by nanopillar arrays and provides the theoretical basis for the design of such nanopillar neural electrodes.

Root surface changes following manual and ultrasonic instrumentation - a scanning electron microscopic study.

OBJECTIVE: The aim of this study is to assess the efficacy of hand and ultrasonic scaling and to evaluate the surface roughness on the root surface of periodontally involved teeth using a scanning electron microscope. PATIENTS AND METHODS: A sample of 90 single-rooted teeth with a hopeless prognosis was selected for the study and divided into three separate groups. Group I consist of no treatment. In Group II, hand scaling was done using Gracey curettes, and in Group III, ultrasonic scaling was done. The teeth were then extracted and fixed in 10% formaldehyde solution for 24-48 hours and subjected to scanning electron microscopic (SEM) evaluation. RESULTS: The SEM analysis revealed that the remaining calculus index was found to be similar in the ultrasonic group and the hand scaling group, whereas the surface roughness was found to be the least in the ultrasonic group. CONCLUSIONS: Hand instrumentation has resulted in more surface roughness as compared to ultrasonic instruments.