Real-World Evaluation of the Off-the-Shelf Precannulated Inner-Branched Endograft for Pararenal Aortic Aneurysms.

PURPOSE: To analyze the early performance and efficacy of the first commercially available off-the-shelf precannulated multibranched endograft in the endovascular repair of pararenal abdominal aortic aneurysms (PAAAs). The device received European marketing approval in late 2020. MATERIALS AND METHODS: Between January 2021 and June 2023, a retrospective analysis of prospectively collected data from all consecutive patients with pAAAs undergoing implantation of the E-nside precannulated inner-branched endograft was conducted in 2 centers. The primary outcome measure was technical success defined as the composite endpoint of successful (1) delivery of the 24F endograft, (2) use of the precannulation tubes, and (3) implantation of the bridging stent-grafts (BSGs) to the target vessels. Main secondary endpoints were mortality, target vessel instability (TVI), absence of type I or III endoleak, reintervention, spinal cord ischemia, and supra-celiac aortic coverage. RESULTS: Twenty-one patients (20 men, mean age: 71 years) were included in this study with a mean follow-up of 14±7.7 months. Nine patients had a symptomatic aneurysm (43%). Technical success amounted to 95% (in one patient, an iliofemoral conduit was necessary to advance the device). One out of 112 BSGs (1%, right renal artery) occluded at 30 days, resulting in freedom from TVI and reintervention rate at 12 months of 95%. No type I or III endoleaks were identified during follow-up. One patient (5%) died at 13 months due to non-aneurysm-related death, and 1 patient (5%) developed spinal cord ischemia. No other major perioperative complications were observed. Mean supra-celiac aortic coverage reached 52±8%. CONCLUSIONS: Given the imperative need for an off-the-shelf endograft tailored to address PAAAs, the E-nside stent-graft demonstrated encouraging outcomes in this study. Nevertheless, it is essential to emphasize that the extent of aortic coverage mandates the production of a truncated variant. CLINICAL IMPACT: The endovascular repair of urgent pararenal aortic aneurysms remains still an unsolved problem in the endovascular era since there are no available off-the-shelf dedicated fenestrated or branched endografts. This paper confirms the safety and efficacy of the off-the-shelf precannulated inner branched endograft for this specific indication.

Cost-Effective Data Acquisition Systems for Advanced Structural Health Monitoring.

With the growing demand for infrastructure and transportation facilities, the need for advanced structural health monitoring (SHM) systems is critical. This study introduces two innovative, cost-effective, standalone, and open-source data acquisition devices designed to enhance SHM through the latest sensing technologies. The first device, termed CEDAS_acc, integrates the ADXL355 MEMS accelerometer with a RaspberryPi mini-computer, ideal for measuring strong ground motions and assessing structural modal properties during forced vibration tests and structural monitoring of mid-rise buildings. The second device, CEDAS_geo, incorporates the SM24 geophone sensor with a Raspberry Pi, designed for weak ground motion measurements, making it suitable for seismograph networks, seismological research, and early warning systems. Both devices function as acceleration/velocity Data Acquisition Systems (DAS) and standalone data loggers, featuring hardware components such as a single-board mini-computer, sensors, Analog-to-Digital Converters (ADCs), and micro-SD cards housed in protective casings. The CEDAS_acc includes a triaxial MEMS accelerometer with three ADCs, while the CEDAS_geo uses horizontal and vertical geophone elements with an ADC board. To validate these devices, rigorous tests were conducted. Offset Test, conducted by placing the sensor on a leveled flat surface in six orientations, demonstrating the accelerometer's ability to provide accurate measurements using gravity as a reference; Frequency Response Test, performed at the Gebze Technical University Earthquake and Structure Laboratory (GTU-ESL), comparing the devices' responses to the GURALP-5TDE reference sensor, with CEDAS_acc evaluated on a shaking table and CEDAS_geo's performance assessed using ambient vibration records; and Noise Test, executed in a low-noise rural area to determine the intrinsic noise of CEDAS_geo, showing its capability to capture vibrations lower than ambient noise levels. Further field tests were conducted on a 10-story reinforced concrete building in Gaziantep, Turkey, instrumented with 8 CEDAS_acc and 1 CEDAS_geo devices. The building's response to a magnitude 3.2 earthquake and ambient vibrations was analyzed, comparing results to the GURALP-5TDE reference sensors and demonstrating the devices' accuracy in capturing peak accelerations and modal frequencies with minimal deviations. The study also introduced the Record Analyzer (RECANA) web application for managing data analysis on CEDAS devices, supporting various data formats, and providing tools for filtering, calibrating, and exporting data. This comprehensive study presents valuable, practical solutions for SHM, enhancing accessibility, reliability, and efficiency in structural and seismic monitoring applications and offering robust alternatives to traditional, costlier systems.

A new guide for enhancing dental implant placement: an in vitro assessment of accuracy.

This study aimed to design a new surgical guide for controlling the mesiodistal distance between implant osteotomies and adjacent teeth as well as the osteotomy depth in partially edentulous patients. The guide kit was designed with design software and milled with a CNC (computer numerical control) router. The guide consisted of 2 components-stoppers and crown guides-for determining the drilling depth and mesiodistal position, respectively. The stoppers were designed in 7.5-, 9.5-, and 11.5-mm lengths, and the crown guides were fabricated with outer diameters of 5.0, 6.0, 7.0, and 8.0 mm. The accuracy of the guide was assessed by preparing a total of 20 implant osteotomies in 4 partially edentulous models and comparing the dimensions of the actual osteotomies to the values that were predicted to occur with the use of the surgical guides. Osteotomies were prepared using the 7.5-mm stopper with either the 7.0- or 8.0-mm crown guide. Cone beam computed tomography (CBCT) was used to obtain images for analysis of osteotomy-tooth mesiodistal distances, which were predicted to be 3.0 or 5.5 mm, depending on position; interosteotomy mesiodistal distances, which were predicted to be 3.0 mm; and osteotomy depth, which was predicted to be 11.5 mm. A 1-sample t test was used to determine if there were significant differences between the predicted values and the measurements of the guided osteotomies on the CBCT images of the mandibular models, and an independent t test was conducted to compare the results of 3.0- and 5.5-mm osteotomy-tooth distances (α = 0.05). Differences between the predicted and actual values of the interosteotomy mesiodistal distance (P = 0.516) and osteotomy depth (P = 0.847) were not statistically significant. The actual osteotomy-tooth mesiodistal distances were significantly different from the predicted values of 3.0 (P = 0.000) and 5.5 mm (P = 0.001), with higher mean differences of 0.46 and 0.60 mm, respectively. The designed guide had a high accuracy in achieving optimal linear interosteotomy mesiodistal distances and osteotomy depths, and the obtained mean values were clinically acceptable.

Common Designs of Custom-Made Fenestrated Arch Devices and Applicability of an Off-the-Shelf Design.

OBJECTIVES: To analyze device designs, similarities and overlaps of custom-made fenestrated arch endografts intended for mid/distal arch thoracic endovascular aortic repair. MATERIALS AND METHODS: A multicenter cross-sectional study analyzing custom-made anonymized graft plans was performed. Graft plans were included from a cohort of mid/distal aortic arch repairs using custom-made fenestrated aortic endografts treated at 8 centers. Grafts targeting >2 arteries were excluded. No patient/clinical data were analyzed. A descriptive analysis was performed followed by an analysis of overlap of the designs to reach a common design in which the greatest number of grafts would overlap. RESULTS: One hundred thirty-one graft plans were included. All grafts were custom-made grafts from the COOK Medical Fenestrated arch platform. Ninety-four (71.8%) had a scallop-and-single-fenestration design, 33 (25.2%) had a single fenestration and 4 (4.3%) a single scallop. For analysis purposes, these latter 4 grafts were excluded. Two main graft plans (Plans 1 and 2) were proposed after analysis with similar configuration (1 scallop with 30 mm width, 20 mm height, 12:00 position; 1 preloaded fenestration with 8 mm diameter, 26 mm from the top of the graft and 12:00 position; tapered, with a 193 mm length and 32 mm distal diameter) but with 2 different proximal diameters of 38 mm (Plan 1) and 44 mm (Plan 2), reaching an overall feasibility of 85.8% (n=109), being 47.2% (n=60) and 38.6% (n=49) for each design, respectively. CONCLUSION: The degree of overlap between the studied fenestrated and/or scalloped thoracic endovascular aneurysm repair (TEVAR) graft designs was high. Future studies analyzing these designs in a real-world cohort of patients are needed to further address off-the-shelf feasibility. CLINICAL IMPACT: In a multicenter study analyzing 127 fenestrated aortic arch endograft plans from 9 aortic centers, we found that the degree of overlap between the studied fenestrated and/or scalloped arch graft designs was high and that 2 proposed graft designs would be theoretically applicable in 85.8% of cases. Future studies analyzing these designs in a real-world cohort of patients are needed to further address off-the-shelf feasibility.

Non-Contact Irreversible Electroporation in the Esophagus With a Wet Electrode Approach.

Our objective was to develop a technique for performing irreversible electroporation (IRE) of esophageal tumors while mitigating thermal damage to the healthy lumen wall. We investigated noncontact IRE using a wet electrode approach for tumor ablation in a human esophagus with finite element models for electric field distribution, joule heating, thermal flux, and metabolic heat generation. Simulation results indicated the feasibility of tumor ablation in the esophagus using an catheter mounted electrode immersed in diluted saline. The ablation size was clinically relevant, with substantially lesser thermal damage to the healthy esophageal wall when compared to IRE performed by placing a monopolar electrode directly into the tumor. Additional simulations were used to estimate ablation size and penetration during noncontact wet-electrode IRE (wIRE) in the healthy swine esophagus. A novel catheter electrode was manufactured and wIRE evaluated in seven pigs. wIRE was performed by securing the device in the esophagus and using diluted saline to isolate the electrode from the esophageal wall while providing electric contact. Computed tomography and fluoroscopy were performed post-treatment to document acute lumen patency. Animals were sacrificed within four hours following treatment for histologic analysis of the treated esophagus. The procedure was safely completed in all animals; post-treatment imaging revealed intact esophageal lumen. The ablations were visually distinct on gross pathology, demonstrating full thickness, circumferential regions of cell death (3.52 ± 0.89 mm depth). Acute histologic changes were not evident in nerves or extracellular matrix architecture within the treatment site. Catheter directed noncontact IRE is feasible for performing penetrative ablations in the esophagus while avoiding thermal damage.

Intensive and Efficient Design of a Two-dimensional 8 × 8 Silicon-Based Optical Phased Array Transceiver.

In recent years, the silicon-based optical phased array has been widely used in the field of light detection and ranging (LIDAR) due to its great solid-state steering ability. At the same time, the optical phased array transceiver integration scheme provides a feasible solution for low-cost information exchange of small devices in the future. Based on this, this paper designs a two-dimensional optical phased array transceiver with high efficiency and a large field of view, which can realize a dense array with antenna spacing of 5.5 µm × 5.5 µm by using low crosstalk waveguide wiring. Additionally, it can realize the conversion between the receiving mode and the transmitting mode by using the optical switch. The simulation results show that the scanning range of 16.3° × 16.3° can be achieved in the transmitting mode, and the overall loss is lower than 10dB. In the receiving mode, we can achieve a collection efficiency of more than 27%, and the antenna array receiving loss is lower than 12.1 dB.

What MEMS Research and Development Can Learn from a Production Environment.

The intricate interdependency of device design and fabrication process complicates the development of microelectromechanical systems (MEMS). Commercial pressure has motivated industry to implement various tools and methods to overcome challenges and facilitate volume production. By now, these are only hesitantly being picked up and implemented in academic research. In this perspective, the applicability of these methods to research-focused MEMS development is investigated. It is found that even in the dynamics of a research endeavor, it is beneficial to adapt and apply tools and methods deduced from volume production. The key step is to change the perspective from fabricating devices to developing, maintaining and advancing the fabrication process. Tools and methods are introduced and discussed, using the development of magnetoelectric MEMS sensors within a collaborative research project as an illustrative example. This perspective provides both guidance to newcomers as well as inspiration to the well-versed experts.

The Impact of Burr Hole Device and Lead Design on Deep Brain Stimulation Lead Stability in Benchtop and Ovine Models.

BACKGROUND AND OBJECTIVES: A market-released deep brain stimulation (DBS) lead and burr hole device (BHD) have been used for more than ten years to provide stable DBS therapy using leads with four equally distributed cylindrical electrodes along the distal lead length. Newer directional leads cluster segmented electrodes at the center of the electrode array. This work tests the hypothesis that improved chronic translational and rotational stability through enhanced BHD design may ensure that these newer directional electrodes remain in a stable orientation near the stimulation target to maintain therapy and maximize opportunities to adjust therapy, if needed. MATERIALS AND METHODS: A new DBS lead system (commercially available in the United States and termed "new" throughout the manuscript) has been developed, and a combination of bench testing (45 product samples tested) and chronic sheep studies (17 animals followed for 13.5 weeks on average) was conducted to test the hypothesis that design changes incorporated into the new DBS system further stabilize the position and orientation of a DBS lead tip compared with a legacy DBS system. RESULTS: The new DBS system demonstrated a 55% relative improvement in chronic lead tip stability compared with the legacy DBS system with over a decade of clinical use. In a bench test, the new system required 79% more applied torque and 203% more lead body revolutions to rotate the lead in the BHD than the legacy system that was not designed to offer rotational stability. CONCLUSIONS: These measurements quantitatively demonstrate that DBS system design can positively improve lead translational and rotational stability and show that system design is an important consideration for future product development.

Humidity Sensitivity of Chemically Synthesized ZnAl2O4/Al.

Humidity sensitivity is evaluated for chemically synthesized ZnAl2O4/Al devices. We succeeded in synthesizing the ZnAl2O4/Al device by applying chemical techniques only. Hydrothermal treatment for the anodized aluminum (AlOx/Al) gives us the device of the ZnAl2O4/Al structure. All fabrication processes were conducted under 400 °C. The key was focusing on ZnAl2O4 as the sensing material instead of MgAl2O4, which is generally investigated as the humidity sensor. The evaluation of this ZnAl2O4/Al device clarified its effectiveness as a sensor. Both electrical capacitance, Cp, and the resistivity, Rp, measured by an LCR meter, obviously responded to the humidity with good sensitivity and appreciable repeatability. Our synthesis technique is possible in principle to improve on the process for the device with a complex structure providing a large surface area. These characteristics are believed to expand the application study of spinel aluminate devices as the sensor.

Design and pre-clinical evaluation of a folding magnetic anastomosis device for minimally invasive surgery.

Objective: This work presents the results of Benchtop tests and pre-clinical study of a novel design for a foldable magnetic anastomosis device. The device can be deployed through an endoscope device channel and fold into a ring larger than the deployment port. This new design enables the target application in JJ-anastomosis creation.Material and methods: The folding anastomosis device is constructed from a chain of permanent magnets suspended in a suture weaving inspired by the contact-aided compliant mechanisms. The device was deployed through an endoscope in Benchtop experiments and its expected coupling force was measured in a pull test. A set of experiments was executed during the pre-clinical study, where the device was deployed in the abdomen, to estimate the reliability of deployment and the plausibility of the use in jejuno-jejunal (JJ)- and gastrojejunal (GJ)-anastomosis creation.Results: The presented folding anastomosis device was shown to deploy through an endoscope device channel and a catheter with an inner diameter of 3.2 mm. After deployment the device folds reliably into a ring with an outer diameter of 7-8 mm. The folded device was shown to exhibit a coupling force comparable to similar cases of JJ-anastomosis creation. It is concluded that the presented design of a folding magnetic ring is suitable for select cases of magnetic compression anastomosis where the device is either delivered through a catheter to fold into an anastomosis ring larger than the deployment port or through an endoscopes device channel to allow for convenient visual confirmation of the device during placement.

Progress on developing an effective below-the-knee drug-coated balloon.

Infrapopliteal atherosclerotic disease continues to present the greatest conundrum for effective endovascular therapies. To date, conventional angioplasty has been fraught with early restenosis and recoil in these complex, long, calcified, and occlusive lesions. The success of metallic drug-eluting stents in coronary arteries has not carried over to below-the-knee arteries. Initial promise in paclitaxel-coated balloons has not been demonstrated in large randomized clinical trials. Furthermore, the potential association between paclitaxel and mortality continues to generate tremendous controversy. The goal of this review article is to discuss the evolution and challenges of drug-coated balloon (DCB) science, present the clinical results of currently available tibial DCBs, and introduce new horizons in DCB technology.

A framework for designing medical devices resilient to low-resource settings.

BACKGROUND: To date (April 2021), medical device (MD) design approaches have failed to consider the contexts where MDs can be operationalised. Although most of the global population lives and is treated in Low- and Middle-Income Countries (LMCIs), over 80% of the MD market share is in high-resource settings, which set de facto standards that cannot be taken for granted in lower resource settings. Using a MD designed for high-resource settings in LMICs may hinder its safe and efficient operationalisation. In the literature, many criteria for frameworks to support resilient MD design were presented. However, since the available criteria (as of 2021) are far from being consensual and comprehensive, the aim of this study is to raise awareness about such challenges and to scope experts' consensus regarding the essentiality of MD design criteria. RESULTS: This paper presents a novel application of Delphi study and Multiple Criteria Decision Analysis (MCDA) to develop a framework comprising 26 essential criteria, which were evaluated and chosen by international experts coming from different parts of the world. This framework was validated by analysing some MDs presented in the WHO Compendium of innovative health technologies for low-resource settings. CONCLUSIONS: This novel holistic framework takes into account some domains that are usually underestimated by MDs designers. For this reason, it can be used by experts designing MDs resilient to low-resource settings and it can also assist policymakers and non-governmental organisations in shaping the future of global healthcare.

Design Considerations for a Surface Disinfection Device Using Ultraviolet-C Light-Emitting Diodes.

Ultraviolet-C (UV-C) radiation, spanning wavelengths between 200 nm and 280 nm, has proven germicidal qualities and medical, industrial, and environmental applications. The need for new disinfection technologies and the prospect of eliminating mercury-based radiation sources compels research on ultraviolet (UV) light-emitting diodes (LEDs). UV-LED technology could be used for customized and point-of-use products for disinfection and sterilization. We focused on the design and development of a surface disinfection device using UV-C LEDs, including potential user targets, important design parameters, and final validation methods. Optical and thermal simulations were used to illustrate the design process and associated challenges. A sample device prototype was developed, and microbial validation results are presented.

Moving toward a Handheld "Plasma" Spectrometer for Elemental Analysis, Putting the Power of the Atom (Ion) in the Palm of Your Hand.

Many of the current innovations in instrument design have been focused on making them smaller, more rugged, and eventually field transportable. The ultimate application is obvious, carrying the instrument to the field for real time sample analysis without the need for a support laboratory. Real time data are priceless when screening either biological or environmental samples, as mitigation strategies can be initiated immediately upon the discovery that contaminant metals are present in a location they were not intended to be. Additionally, smaller "handheld" instruments generally require less sample for analysis, possibly increasing sensitivity, another advantage to instrument miniaturization. While many other instruments can be made smaller just by using available micro-technologies (e.g., eNose), shrinking an ICP-MS or AES to something someone might carry in a backpack or pocket is now closer to reality than in the past, and can be traced to its origins based on a component-by-component evaluation. While the optical and mass spectrometers continue to shrink in size, the ion/excitation source remains a challenge as a tradeoff exists between excitation capabilities and the power requirements for the plasma's generation. Other supporting elements have only recently become small enough for transport. A systematic review of both where the plasma spectrometer started and the evolution of technologies currently available may provide the roadmap necessary to miniaturize the spectrometer. We identify criteria on a component-by-component basis that need to be addressed in designing a miniaturized device and recognize components (e.g., source) that probably require further optimization. For example, the excitation/ionization source must be energetic enough to take a metal from a solid state to its ionic state. Previously, a plasma required a radio frequency generator or high-power DC source, but excitation can now be accomplished with non-thermal (cold) plasma sources. Sample introduction, for solids, liquids, and gasses, presents challenges for all sources in a field instrument. Next, the interface between source and a mass detector usually requires pressure reduction techniques to get an ion from plasma to the spectrometer. Currently, plasma mass spectrometers are field ready but not necessarily handheld. Optical emission spectrometers are already capable of getting photons to the detector but could eventually be connected to your phone. Inert plasma gas generation is close to field ready if nitrogen generators can be miniaturized. Many of these components are already commercially available or at least have been reported in the literature. Comparisons to other "handheld" elemental analysis devices that employ XRF, LIBS, and electrochemical methods (and their limitations) demonstrate that a "cold" plasma-based spectrometer can be more than competitive. Migrating the cold plasma from an emission only source to a mass spectrometer source, would allow both analyte identification and potentially source apportionment through isotopic fingerprinting, and may be the last major hurdle to overcome. Finally, we offer a possible design to aid in making the cold plasma source more applicable to a field deployment.

Infusion Jet Flow Control in Neonatal Double Lumen Cannulae.

Clinical success of extracorporeal membrane oxygenation (ECMO) depends on the proper venous cannulation. Venovenous (VV) ECMO is the preferred clinical intervention as it provides a single-site access by utilizing a VV double lumen cannula (VVDLC) with a higher level of mobilization and physical rehabilitation. Concurrent venous blood drainage and oxygenated blood infusion in the right atrium at the presence of the cannula makes the flow dynamics complex where potential mixing of venous and oxygenated blood can drastically decrease the overall performance of ECMO. There are no studies focusing on the neonatal and pediatric populations, in which the flow related effects are critical due to the small atrium size. In this study, fluid dynamics of infusion outflow jet for two commercially available neonatal VVDLC is analyzed using particle image velocimetry (PIV). Moreover, six new designs are proposed for the infusion channel geometry and compared. Important flow parameters such as flow turning angle (FTA), velocity decay, potential core, and turbulent intensity are investigated for the proposed models. The experiments showed that the outflow parameters of commercial cannulae such as FTA are strongly dependent on the operating Re number. This may result in a drastic efficiency reduction for cannula operating at off-design flow conditions. Moreover, the infusion outlet tip structure and jet internal guiding pathway (JIGP) was observed to greatly affect the outflow flow features. This is of paramount importance since the anatomical positioning of the cannula and the infusion outlet is strongly dependent on the outflow properties such as FTA.

Device for Contact Measurement of Turbine Blade Geometry in Robotic Grinding Process.

The article discusses the design, implementation, and testing of the accuracy of a measuring device used to measure the thickness of aircraft engine blades subjected to a robotic grinding process. The assumptions that the measuring device should meet were presented. The manufactured device was subjected to accuracy and repeatability tests using a standard workpiece. The analysis of research results proved that the measuring device exhibits an accuracy of one order of magnitude better than the accuracy required for blades. For control of the grinding process, the results should be perceived as appropriate. Then, the device was subjected to verification consisting in using it to measure the thickness of aircraft engine blades. The constructed device can be used, not only for inspection of final products, but also for control of the robotic grinding process because thanks to the output interface it can be used in the robotic station's feedback loop.

Flexible Zn-Ion Batteries: Recent Progresses and Challenges.

To keep pace with the increasing pursuit of portable and wearable electronics, it is urgent to develop advanced flexible power supplies. In this context, Zn-ion batteries (ZIBs) have garnered increasing attention as favorable energy storage devices for flexible electronics, owing to the high capacity, low cost, abundant resources, high safety, and eco-friendliness. Extensive efforts have been devoted to developing flexible ZIBs in the last few years. This work summarizes the recent achievements in the design, fabrication, and characterization of flexible ZIBs. Representative structures, such as sandwich and cable type, are particularly highlighted. Special emphasis is put on the novel design of electrolyte and electrode, which aims to endow reliable flexibility to the fabricated ZIBs. Moreover, current challenges and future opportunities for the development of high-performance flexible ZIBs are also outlined.

Li4 Ti5 O12 Anode: Structural Design from Material to Electrode and the Construction of Energy Storage Devices.

Spinel Li4 Ti5 O12 , known as a zero-strain material, is capable to be a competent anode material for promising applications in state-of-art electrochemical energy storage devices (EESDs). Compared with commercial graphite, spinel Li4 Ti5 O12 offers a high operating potential of ∼1.55 V vs Li/Li+ , negligible volume expansion during Li+ intercalation process and excellent thermal stability, leading to high safety and favorable cyclability. Despite the merits of Li4 Ti5 O12 been presented, there still remains the issue of Li4 Ti5 O12 suffering from poor electronic conductivity, manifesting disadvantageous rate performance. Typically, a material modification process of Li4 Ti5 O12 will be proposed to overcome such an issue. However, the previous reports have made few investigations and achievements to analyze the subsequent processes after a material modification process. In this review, we attempt to put considerable interest in complete device design and assembly process with its material structure design (or modification process), electrode structure design and device construction design. Moreover, we have systematically concluded a series of representative design schemes, which can be divided into three major categories involving: (1) nanostructures design, conductive material coating process and doping process on material level; (2) self-supporting or flexible electrode structure design on electrode level; (3) rational assembling of lithium ion full cell or lithium ion capacitor on device level. We believe that these rational designs can give an advanced performance for Li4 Ti5 O12 -based energy storage device and deliver a deep inspiration.

In Vitro Evaluation of Aortic Stent Graft Deployment Accuracy in the Distal Landing Zone.

OBJECTIVES: Thoracic endovascular aortic repair technology focuses on accurately deploying the stent graft in the proximal landing zone in the proximal to distal direction. The aim of this in vitro study was to evaluate the accuracy of stent graft deployment in the distal landing zone. METHODS: It was hypothesised that a reverse implantation mechanism (in a distal to proximal deployment direction, when the operator starts to open the endoprosthesis from distal to proximal), might enhance landing accuracy in the distal LZ. The aim was to investigate this hypothesis by implanting stent grafts into the 3D printed aortas with the currently available deployment mechanism. Based on two human patients' computed tomography angiography scans, two aortas were 3D printed at 1:1 scale: "straight" and "crooked" aortas with distal aortic tortuosity of 1.006 and 1.078, respectively. They were used in order to test three endoprostheses (E-vita THORACIC 3G, Relay Plus, Valiant Captivia) 10 times by implanting them in three ways: proximal landing in the aneurysm, proximal landing in another stent graft, reverse implantation (via simulated antegrade access). The aim was to land just above the target vessel's upper edge. The distance to the target vessel and wedge apposition were assessed under a direct view using caliper. RESULTS: The distance to the target vessel was 3 mm (IQR 0; 8) if the stent graft landed proximally in aneurysm, 2 mm (IQR 0; 5) if it landed proximally in another stent graft, and 0 mm (IQR 0; 0) when reverse implantation was applied. The distance to the target vessel measuring 5 mm or occurred in 45%, 30%, and 0%, respectively. Overall the median wedge apposition after stent graft implantation was 0 mm (IQR 0; 0) in the "straight" versus 18 mm (IQR 15; 20) in the "crooked" aorta (p < .001). CONCLUSIONS: Reverse stent graft deployment is associated with more accurate landing in the distal landing zone. Distal aortic tortuosity constitutes an important impediment to covering the distal LZ's entire circumference with a stent graft.

Good Things in Small Packages: an Innovative Delivery Approach for Inhaled Insulin.

PURPOSE: The design development of a small, hand held, battery operated, breath actuated inhaler as a drug/device platform for inhaled insulin posed a number of technical challenges. Our goal was to optimize lung deposition and distribution with aerosol generators producing 3-6 µm particle size distribution. METHODS: In silico modeling with computational fluid dynamics (CFD) and in vitro testing of device components were assessed using an Alberta idealized adult airway (Copley, UK) to optimize mouthpiece and aerosol path design for dose delivered distal to the trachea. Human factors use testing was designed to determine the ability to perform inspiratory manuevers with LED guidance within target flow limits. In vivo testing with healthy normal subjects of radiolabeled aerosol compared 2 breathing patterns for lung deposition efficiency, distribution, and subject preference. RESULTS: CFD demonstrated that flows ≤5 L/min and ≥15 L/min reduced the delivery efficiencg. Prototypes tested with inspiratory flow of 10 L/min provided up to 70% of dose delivered distal to the model throat with aerosols of 3 to 6 µm. Users guided by LED were able to inhale for 8-24 s with 5 s breath hold. Lung dose >70% with peripheral to central ratios >2.0 were achieved, with subject preference for the longer inspiratory time with breath hold. CONCLUSION: The device design phase integration led to a novel design and inspiratory pattern with greater levels of peripheral deposition than previously reported with commercial inhalers. The rationale and process of the application of these methods are described with implications for use in future device development.