Development and Validation of a Low-Cost Device for Real-Time Detection of Fatigue Damage of Structures Subjected to Vibrations.

This paper presents the development and validation of a low-cost device for real-time detection of fatigue damage of structures subjected to vibrations. The device consists of an hardware and signal processing algorithm to detect and monitor variations in the structural response due to damage accumulation. The effectiveness of the device is demonstrated through experimental validation on a simple Y-shaped specimen subjected to fatigue loading. The results show that the device can accurately detect structural damage and provide real-time feedback on the health status of the structure. The low-cost and easy-to-implement nature of the device makes it promising for use in structural health monitoring applications in various industrial sectors.

Development of an In Vitro Hemorrhagic Hydrocephalus Model for Functional Evaluation of Magnetic Microactuators Against Shunt Obstructions.

OBJECTIVE: Occlusion of ventriculoperitoneal shunts placed after intraventricular hemorrhage occurs frequently. The objective of this study was to develop a hemorrhagic hydrocephalus model to assess the ability of an oscillating microactuator within the ventricular catheter (VC) to prevent shunt obstruction. METHODS: An in vitro hydrocephalus model with extreme risk of shunt obstruction was created. Phosphate-buffered saline, blood, and thrombin were driven through ventriculoperitoneal shunts for 8 hours. Five VCs were fitted with a microactuator and compared with 5 control VCs. The microactuator was actuated by an external magnetic field for 30 minutes. Pressure within the imitation lateral ventricle was measured. RESULTS: In the 5 control shunts, 6 obstructions developed (3 VC, 3 valve-distal catheter) compared with 1 obstruction (VC) in the 5 microactuator shunts. In the control and microactuator groups, the median volume exiting the shunts in 8 hours was 30 mL versus 256 mL. Median time to reach an intraventricular pressure of 40 mm Hg (13.8 minutes vs. >8 hours), median total time >40 mm Hg (6.2 hours vs. 0.0 hours), and median maximum pressure (192 mm Hg vs. 36 mm Hg) were significantly improved in the microactuator group (P < 0.01). CONCLUSIONS: In addition to protecting the VC, the microactuator appeared to prevent hematoma obstructing the valve or distal catheter, resulting in a much longer duration of low intraventricular pressures. A microactuator activated by placing the patient's head in an external magnetic field could reduce shunt obstructions in hemorrhagic hydrocephalus.

Advanced Data Analytics for Clinical Research Part II: Application to Cardiothoracic Surgery.

In the first part of this series, we introduced the tools of Big Data, including Not Only Standard Query Language data warehouse, natural language processing (NLP), optical character recognition (OCR), and Internet of Things (IoT). There are nuances to the utilization of these analytics tools, which must be well understood by clinicians seeking to take advantage of these innovative research strategies. One must recognize technical challenges to NLP, such as unintended search outcomes and variability in the expression of human written texts. Other caveats include dealing written texts in image formats, which may ultimately be handled with transformation to text format by OCR, though this technology is still under development. IoT is beginning to be used in cardiac monitoring, medication adherence alerts, lifestyle monitoring, and saving traditional labs from equipment failure catastrophes. These technologies will become more prevalent in the future research landscape, and cardiothoracic surgeons should understand the advantages of these technologies to propel our research to the next level. Experience and understanding of technology are needed in building a robust NLP search result, and effective communication with the data management team is a crucial step in successful utilization of these technologies. In this second installment of the series, we provide examples of published investigations utilizing the advanced analytic tools introduced in Part I. We will explain our processes in developing the research question, barriers to achieving the research goals using traditional research methods, tools used to overcome the barriers, and the research findings.

Prediction of the service life of surgical instruments from the surgical instrument management system log using radio frequency identification.

BACKGROUND: Bar code- or radio frequency identification (RFID)-based medical instrument management systems have gradually been introduced in the field of surgical medicine for the individual management and identification of instruments. We hypothesized that individual management of instruments using RFID tags can provide previously unavailable information, particularly the precise service life of an instrument. Such information can be used to prevent medical accidents caused by surgical instrument failure. This study aimed to predict the precise service life of instruments by analyzing the data available in instrument management systems. METHODS: We evaluated the repair history of instruments and the usage count until failure and then analyzed the data by the following three methods: the distribution of the instrument usage count was determined, an instrument failure probability model was generated through logistic regression analysis, and survival analysis was performed to predict instrument failure. RESULTS: The usage count followed a normal distribution. Analysis showed that instruments were not used uniformly during surgery. In addition, the Kaplan-Meier curves plotted for five types of instruments showed significant differences in the cumulative survival rate of different instruments. CONCLUSIONS: The usage history of instruments obtained with RFID tags or bar codes can be used to predict the probability of instrument failure. This prediction is significant for determining the service life of an instrument. Implementation of the developed model in instrument management systems can help prevent accidents due to instrument failure. Knowledge of the instrument service life will also help in developing a purchase plan for instruments to minimize wastage.

Sound analysis of the magnetically levitated left ventricular assist device HeartMate 3™.

INTRODUCTION: The HeartMate 3™ has shown lower rates of adverse events compared to previous devices due to the design and absence of mechanical bearings. For previous devices, sound analysis emerged as a way to assess pump function. The aims of this study were to determine if sound analysis can be applied to the HeartMate 3 in vivo and in vitro and to evaluate an electronic stethoscope. METHOD: Sound recordings were performed with microphones and clinical accessible electronic stethoscope. The recordings were studied in both the time and the frequency domains. Recordings from four patients were performed to determine if in vivo and in vitro recordings are comparable. RESULTS: The results show that it is possible to detect sound from HeartMate 3 and the sound spectrum is clear. Pump frequency and frequency of the pulsatile mode are easily determined. Frequency spectra from in vitro and in vivo recordings have the same pattern, and the major proportion (96.7%) of signal power is located at the pump speed frequency ±40 Hz. The recordings from the patients show low inter-individual differences except from location of peaks originating from pump speed and harmonics. Electronic stethoscopes could be used for sound recordings, but the dedicated equipment showed a clearer sound spectrum. DISCUSSION: The results show that acoustic analysis can also be performed with the HeartMate 3 and that in vivo and in vitro sound spectrum is similar. The frequency spectra are different from previous devices, and methods for assessing pump function or thrombosis need further evaluation.

Using a Support Vector Machine Based Decision Stage to Improve the Fault Diagnosis on Gearboxes.

Gearboxes are mechanical devices that play an essential role in several applications, e.g., the transmission of automotive vehicles. Their malfunctioning may result in economic losses and accidents, among others. The rise of powerful graphical processing units spreads the use of deep learning-based solutions to many problems, which includes the fault diagnosis on gearboxes. Those solutions usually require a significant amount of data, high computational power, and a long training process. The training of deep learning-based systems may not be feasible when GPUs are not available. This paper proposes a solution to reduce the training time of deep learning-based fault diagnosis systems without compromising their accuracy. The solution is based on the use of a decision stage to interpret all the probability outputs of a classifier whose output layer has the softmax activation function. Two classification algorithms were applied to perform the decision. We have reduced the training time by almost 80% without compromising the average accuracy of the fault diagnosis system.

Effects of artificial aging and progression of cracks on thin occlusal veneers using SD-OCT.

OBJECTIVES: The purpose of this study was to evaluate the effects of artificial aging on thin glass-ceramic occlusal premolar veneers, adhesively bonded to dentin, by examining the changes caused by artificial aging using spectral domain optical coherence tomography (SD-OCT). In addition, the development of cracks in the ceramic veneers and their possible influence on the behavior of the ceramic restorations were examined. METHODS: In total, 48 extracted sound upper premolars were prepared in the dentin for occlusal veneers milled from lithium disilicate ceramic blocks (IPS e.max CAD, Ivoclar Vivadent, Liechtenstein). All restorations were adhesively bonded using resin cement (Variolink Esthetic DC, Ivoclar Vivadent). Specimens were 3-dimensionally and 2-dimensionally imaged by SD-OCT (Telesto II, Thorlabs GmbH, Germany), then subjected to thermal-dynamic loading in a chewing simulator with 1,200,000 cycles at a load of 10 kg. Specimens were 2D and 3D imaged again after the artificial aging. Finally, they were subjected to quasi-static loading using a universal testing machine until failure occurred and later examined microscopically to assess the mode of failure. ANOVA test was performed for statistical analysis of data and Tukey's post-hoc test was used to compare the groups at 5% significance level. Chi-Square Test and Fischer's Exact Test of Independence were conducted to test the association between nominal variables. RESULTS: No changes or irregularities were observed in the cement layer or tooth substrate after the aging process. However, wear of the ceramic was noticed at the surface of contact with the antagonist during the test. The development of cracks was detected in 23% of the specimens. Cracks did not affect the fracture strength (p > 0.05) but influenced the mode of failure (p ≤ 0.001). SIGNIFICANCE: Optical coherence tomography allows an easy and non-invasive method to internally scan teeth and restorations. Development of cracks in the ceramic did not affect the fracture strength of the restorations but might lead to a more catastrophic type of failure.

Scoping the scope: endoscopic evaluation of endoscope working channels with a new high-resolution inspection endoscope (with video).

BACKGROUND AND AIMS: Outbreaks of transmission of infection related to endoscopy despite reported adherence to reprocessing guidelines warrant scrutiny of all potential contributing factors. Recent reports from ambulatory surgery centers indicated widespread significant occult damage within endoscope working channels, raising concerns regarding the potential detrimental impact of this damage on the adequacy of endoscope reprocessing. METHODS: We inspected working channels of all 68 endoscopes at our academic institution using a novel flexible inspection endoscope. Inspections were recorded and videos reviewed by 3 investigators to evaluate and rate channel damage and/or debris. Working channel rinsates were obtained from all endoscopes, and adenosine triphosphate (ATP) bioluminescence was measured. RESULTS: Overall endoscope working channel damage was rated as minimal and/or mild and was consistent with expected wear and tear (median 1.59 on our 5-point scale). Our predominant findings included superficial scratches (98.5%) and scratches with adherent peel (76.5%). No channel perforations, stains, or burns were detected. The extent of damage was not predicted by endoscope age. Minor punctate debris was common, and a few small drops of fluid were noted in 42.6% of endoscopes after reprocessing and drying. The presence of residual fluid predicted higher ATP bioluminescence values. The presence of visualized working channel damage or debris was not associated with elevated ATP bioluminescence values. CONCLUSION: The flexible inspection endoscope enables high-resolution imaging of endoscope working channels and offers endoscopy units an additional modality for endoscope surveillance, potentially complementing bacterial cultures and ATP values. Our study, conducted in a busy academic endoscopy unit, indicated predominately mild damage to endoscope working channels, which did not correlate with elevated ATP values.

Is bearing resistance negligible during wheelchair locomotion? Design and validation of a testing device.

PURPOSE: Among the different resistances occurring during wheelchair locomotion and that limit the user autonomy, bearing resistance is generally neglected, based on a few studies carried out in static conditions and by manufacturer's assertion. Therefore, no special attention is generally paid to the mounting and the maintenance of manual wheelchair bearings. However, the effect of inadequate mounting or maintenance on wheelchair bearing resistance has still to be clarified. This study aimed at filling this gap by developing and validating a specific device allowing the measurement of wheelchair bearing friction, characterized by low speed velocities, with an accuracy lower than 0.003 Nm. METHODS: The bearing resistance measured by the device was compared to free deceleration measurement, intra and inter operator reproducibility were assessed. A factorial experiment allowed the effects of various functioning parameters (axial and radial loads, velocity) to be classified. RESULTS: The device allowed significant differences in the bearing resistance of static and rotating conditions to be measured, even if a relatively high proportionality was found between both conditions. The factorial experiment allowed the expected impact of the radial load on bearing resistance as well as the predominant effect of the axial load to be demonstrated. CONCLUSIONS: As a consequence, it appeared that the control of the axial load is compulsory for measurement purposes or during wheel mounting, to avoid significant increase of global resistance during wheelchair locomotion. The findings of this study could help enhancing the models which assess manual wheelchair mechanical power from its settings and use conditions.

A Novel 141Ce-Based Flood Field Phantom: Assessment of Suitability for Daily Uniformity Testing in a Clinical Nuclear Medicine Department.

Daily quality control testing of a γ-camera is of the utmost importance in assessing whether the camera is suitable for clinical use. The aim of our study was to assess the suitability of a fillable 141Ce-based flood field phantom developed in-house for daily quality control testing of γ-cameras. Methods: Daily uniformity testing was performed for 113 d using the fillable 141Ce phantom and a commercially available sheet-type 57Co phantom, and the results were compared. Results: The average integral uniformity obtained by the 141Ce and 57Co phantoms was 3.24% and 2.72%, respectively, for detector 1 and 3.31% and 2.78%, respectively, for detector 2. Conclusion: The 141Ce phantom we developed is a suitable alternative to the commercially available 57Co phantom.

A mock heart engineered with helical aramid fibers for in vitro cardiovascular device testing.

Mock heart circulation loops (MHCLs) serve as in-vitro platforms to investigate the physiological interaction between circulatory systems and cardiovascular devices. A mock heart (MH) engineered with silicone walls and helical aramid fibers, to mimic the complex contraction of a natural heart, has been developed to advance the MHCL previously developed in our group. A mock aorta with an anatomical shape enables the evaluation of a cannulation method for ventricular assist devices (VADs) and investigation of the usage of clinical measurement systems like pressure-volume catheters. Ventricle and aorta molds were produced based on MRI data and cast with silicone. Aramid fibers were layered in the silicone ventricle to reproduce ventricle torsion. A rotating hollow shaft was connected to the apex enabling the rotation of the MH and the connection of a VAD. Silicone wall thickness, aramid fiber angle and fiber pitch were varied to generate different MH models. All MH models were placed in a tank filled with variable amounts of water and air simulating the compliance. In this work, physiological ventricular torsion angles (15°-26°) and physiological pressure-volume loops were achieved. This MHCL can serve as a comprehensive testing platform for cardiovascular devices, such as artificial heart valves and cannulation of VADs.

A Real-Time Gait Event Detection for Lower Limb Prosthesis Control and Evaluation.

Lower extremity amputees suffer from mobility limitations which will result in a degradation of their quality of life. Wearable sensors are frequently used to assess spatio-temporal, kinematic and kinetic parameters providing the means to establish an interactive control of the amputee-prosthesis-environment system. Gait events and the gait phase detection of an amputee's locomotion are vital for controlling lower limb prosthetic devices. The paper presents an approach to real-time gait event detection for lower limb amputees using a wireless gyroscope attached to the shank when performing level ground and ramp activities. The results were validated using both healthy and amputee subjects and showed that the time differences in identifying Initial Contact (IC) and Toe Off (TO) events were larger in a transfemoral amputee when compared to the control subjects and a transtibial amputee (TTA). Overall, the time difference latency lies within a range of ±50 ms while the detection rate was 100% for all activities. Based on the validated results, the IC and TO events can be accurately detected using the proposed system in both control subjects and amputees when performing activities of daily living and can also be utilized in the clinical setup for rehabilitation and assessing the performance of lower limb prosthesis users.

Technologies for Prolonging Cardiac Implantable Electronic Device Longevity.

Prolonged longevity of cardiac implantable electronic devices (CIEDs) is needed not only as a passive response to match the prolonging life expectancy of patient recipients, but will also actively prolong their life expectancy by avoiding/deferring the risks (and costs) associated with device replacement. CIEDs are still exclusively powered by nonrechargeable primary batteries, and energy exhaustion is the dominant and an inevitable cause of device replacement. The longevity of a CIED is thus determined by the attrition rate of its finite energy reserve. The energy available from a battery depends on its capacity (total amount of electric charge), chemistry (anode, cathode, and electrolyte), and internal architecture (stacked plate, folded plate, and spiral wound). The energy uses of a CIED vary and include a background current for running electronic circuitry, periodic radiofrequency telemetry, high-voltage capacitor reformation, constant ventricular pacing, and sporadic shocks for the cardiac resynchronization therapy defibrillators. The energy use by a CIED is primarily determined by the patient recipient's clinical needs, but the energy stored in the device battery is entirely under the manufacturer's control. A larger battery capacity generally results in a longer-lasting device, but improved battery chemistry and architecture may allow more space-efficient designs. Armed with the necessary technical knowledge, healthcare professionals and purchasers will be empowered to make judicious selection on device models and maximize the utilization of all their energy-saving features, to prolong device longevity for the benefits of their patients and healthcare systems.

Research: Testing of a Novel Portable Body Temperature Conditioner Using a Thermal Manikin.

A battery-operated active cooling/heating device was developed to maintain thermoregulation of trauma victims in austere environments while awaiting evacuation to a hospital for further treatment. The use of a thermal manikin was adopted for this study in order to simulate load testing and evaluate the performance of this novel portable active cooling/heating device for both continuous (external power source) and battery power. The performance of the portable body temperature conditioner (PBTC) was evaluated through cooling/heating fraction tests to analyze the heat transfer between a thermal manikin and circulating water blanket to show consistent performance while operating under battery power. For the cooling/heating fraction tests, the ambient temperature was set to 15°C ± 1°C (heating) and 30°C ± 1°C (cooling). The PBTC water temperature was set to 37°C for the heating mode tests and 15°C for the cooling mode tests. The results showed consistent performance of the PBTC in terms of cooling/heating capacity while operating under both continuous and battery power. The PBTC functioned as intended and shows promise as a portable warming/cooling device for operation in the field.

Simultaneous measurement of friction and wear in hip simulators.

We propose and have evaluated a method to measure hip friction during wear testing on a popular multi-station hip simulator. A 6-degree-of-freedom load cell underneath the specimen sensed forces and torques during implant wear testing of simulated walking. This included internal-external and adduction-abduction rotations which are often neglected during friction testing on pendulum-type machines. Robust mathematical analysis and data processing provided friction estimates in three simultaneous orthogonal rotations, over extended multi-million cycle wear tests. We tested various bearing couples including metal-on-plastic, ceramic-on-plastic, and metal-on-metal material couples. In one test series, new and intentionally scratched CoCrMo 40-mm-diameter femoral heads were tested against conventional ultrahigh-molecular-weight polyethylene, highly cross-linked, and highly cross-linked with vitamin E versions. The scratching significantly increased friction and doubled the wear of all groups. Before scratching, friction levels for the aforementioned plastic groups were 0.056 ± 0.0060, 0.062 ± 0.0080, and 0.070 ± 0.0045, respectively, but after scratching increased to 0.088 ± 0.018, 0.076 ± 0.0066, and 0.082 ± 0.0049, respectively, all statistically significant increases (p = 0.00059, 0.00005, 0.0115, respectively). In another test series of 44-mm femoral head diameter hips, metal-on-plastic hips with conventional ultrahigh-molecular-weight polyethylene showed the lowest friction at 0.045 ± 0.0085, followed by highly cross-linked with 0.046 ± 0.0035 (not significantly different). In a ceramic-on-plastic design with conventional ultrahigh-molecular-weight polyethylene, higher friction 0.079 ± 0.0070 was measured likely due to that ceramic surface being rougher than usual. Metal-on-metal hips were compared without and with a TiN coating, resulting in 0.049 ± 0.014 and 0.097 ± 0.020 friction factors, respectively (statistically significant, p < 0.001), and the coating wore away on all coated hips eventually. Higher friction mostly correlated with higher wear or damage to femoral heads or implant coatings, except for the highly cross-linked wear resistant ultrahigh-molecular-weight polyethylene which had slightly higher friction, confirming the same finding in other independent studies. This type of friction measurements can help screen for clamping and elevated wear of metal-on-metal and resurfacing total hip replacements, surgical malpositioning, and abraded and otherwise damaged surfaces.

Influence of hip joint simulator design and mechanics on the wear and creep of metal-on-polyethylene bearings.

Hip joint simulators are used extensively for preclinical testing of hip replacements. The variation in simulator design and test conditions used worldwide can affect the tribological performance of polyethylene. The aim of this study was to assess the effects of simulator mechanics and design on the wear and creep of ultra-high-molecular-weight polyethylene. In the first part of this study, an electromechanical simulator and pneumatic simulator were used to compare the wear and creep of metal-on-polyethylene components under the same standard gait conditions. In the second part of the study, the same electromechanical hip joint simulator was used to investigate the influence of kinematics on wear. Higher wear rates and penetration depths were observed from the electromechanical simulator compared with the pneumatic simulator. When adduction/abduction was introduced to the gait cycle, there was no significant difference in wear with that obtained under the gait cycle condition without adduction/abduction. This study confirmed the influence of hip simulator design and loading conditions on the wear of polyethylene, and therefore direct comparisons of absolute wear rates between different hip joint simulators should be avoided. This study also confirmed that the resulting wear path was the governing factor in obtaining clinically relevant wear rates, and this can be achieved with either two axes or three axes of rotations. However, three axes of rotation (with the inclusion of adduction/abduction) more closely replicate clinical conditions and should therefore be the design approach for newly developed hip joint simulators used for preclinical testing.

Engineering of a multi-station shoulder simulator.

This work aimed to engineer a multi-station shoulder simulator in order to wear test shoulder prostheses using recognized shoulder activities of daily living. A bespoke simulator was designed, built and subject to commissioning trials before a first wear test was conducted. Five JRI Orthopaedics Reverse Shoulder VAIOS 42 mm prostheses were tested for 2.0 million cycles and a mean wear rate and standard deviation of 14.2 ± 2.1 mm(3)/10(6) cycles measured for the polymeric glenoid components. This result when adjusted for prostheses diameters and test conditions showed excellent agreement with results from hip simulator studies of similar materials in a lubricant of bovine serum. The Newcastle Shoulder Simulator is the first multi-station shoulder simulator capable of applying physiological motion and loading for typical activities of daily living.

Mitral Valve Regurgitation in the LVAD-Assisted Heart Studied in a Mock Circulatory Loop.

Permanent closure of the aortic valve (AVC) is sometimes performed In LVAD patients, usually when a mechanical valve prosthesis or significant aortic insufficiency is present. Mitral valve regurgitation (MVR) present at the time of LVAD implantation can remain unresolved, representing a limitation for exercise tolerance and a potential predictor of mortality. To investigate the effect of MVR on hemodynamics of the LVAD-supported heart following AVC, studies were performed using a mock circulatory loop. Pressure and flow measured for a range of cardiac function, LVAD speed, and MVR show that cardiac contraction augments aortic pressure by 10-27% over nonpulsatile conditions when the mitral valve functions normally, but decreases with MVR until it reaches the nonpulsatile level. Aortic flow displays a similar trend, demonstrating a 25% decrease from fully functioning to open at 7 krpm, a 5% decrease at 9 krpm, and no observable effect at 11 krpm. Pulsatility decreases with increased LVAD speed and MVR. The data indicate that a modest level of cardiac output (1.5-2 L/min) can be maintained by the native heart through the LVAD when the LVAD is off. These results demonstrate that MVR decreases the augmentation of forward flow by improved cardiac function at lower LVAD speeds. While some level of MVR can be tolerated in LVAD recipients, this condition represents a risk, particularly in those patients that undergo AVC closure, and may warrant repair at the time of surgery.