Search results for: implantable defibrillator

Authors: Benn Van Den Ende

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Over the last three decades, there has been an exponential increase in developments in implantable technologies such as the cardiac pacemaker, bionic prosthesis, and implantable chips. The effect of these technologies has been well researched in many areas. However, there is a lack of critical research in security studies. This paper will provide preliminary findings to an ongoing research project which aims to examine how implantable technologies effect the practices of governmentality in the context of security. It will do this by looking at the practices and techniques of governmentality along with different implantable technologies which increase, change or otherwise affect governmental practices. The preliminary research demonstrates that implantable technologies have a profound effect on the practices of governmentality, while also paving the way for further research into a potential ‘new’ form of governmentality in relation to these implantable technologies.

Keywords: critical security studies, governmentality, security theory, political theory, Foucault

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Authors: Taikchan Lildar, Ayesha Samad, Suraj Sookhu

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Atrial fibrillation with rapid ventricular response results in the loss of atrial kick and shortened ventricular filling time, which often leads to decompensated heart failure. Pharmacologic rhythm control is the treatment of choice, and patients frequently benefit from the restoration of sinus rhythm. When pharmacologic treatment is unsuccessful or a patient declines hemodynamically, direct cardioversion is the treatment of choice. Torsades de pointes or “twisting of the points'' in French, is a rare but under-appreciated risk of cardioversion therapy and accounts for a significant number of sudden cardiac death each year. A 61-year-old female with no significant past medical history presented to the Emergency Department with worsening dyspnea. An electrocardiogram showed atrial fibrillation with rapid ventricular response, and a chest X-ray was significant for bilateral pulmonary vascular congestion. Full-dose anticoagulation and diuresis were initiated with moderate improvement in symptoms. A transthoracic echocardiogram revealed biventricular systolic dysfunction with a left ventricular ejection fraction of 30%. After consultation with an electrophysiologist, the consensus was to proceed with the restoration of sinus rhythm, which would likely improve the patient’s heart failure symptoms and possibly the ejection fraction. A transesophageal echocardiogram was negative for left atrial appendage thrombus; the patient was treated with a loading dose of amiodarone and underwent successful direct current cardioversion with 200 Joules. The patient was placed on telemetry monitoring for 24 hours and was noted to have frequent premature ventricular contractions with subsequent degeneration to torsades de pointes. The patient was found unresponsive and pulseless; cardiopulmonary resuscitation was initiated with cardioversion, and return of spontaneous circulation was achieved after four minutes to normal sinus rhythm. Post-cardiac arrest electrocardiogram showed sinus bradycardia with heart-rate corrected QT interval of 592 milliseconds. The patient continued to have frequent premature ventricular contractions and required two additional cardioversions to achieve a return of spontaneous circulation with intravenous magnesium and lidocaine. An automatic implantable cardioverter-defibrillator was subsequently implanted for secondary prevention of sudden cardiac death. The backup pacing rate of the automatic implantable cardioverter-defibrillator was set higher than usual in an attempt to prevent premature ventricular contractions-induced torsades de pointes. The patient did not have any further ventricular arrhythmias after implantation of the automatic implantable cardioverter-defibrillator. Overdrive pacing is a method utilized to treat premature ventricular contractions-induced torsades de pointes by preventing a patient’s susceptibility to R on T-wave-induced ventricular arrhythmias. Pacing at a rate of 90 beats per minute succeeded in controlling the arrhythmia without the need for traumatic cardiac defibrillation. In our patient, conversion of atrial fibrillation with rapid ventricular response to normal sinus rhythm resulted in a slower heart rate and an increased probability of premature ventricular contraction occurring on the T-wave and ensuing ventricular arrhythmia. This case highlights direct current cardioversion for atrial fibrillation with rapid ventricular response resulting in persistent ventricular arrhythmia requiring an automatic implantable cardioverter-defibrillator placement with overdrive pacing to prevent a recurrence.

Keywords: refractory atrial fibrillation, atrial fibrillation, overdrive pacing, torsades de pointes

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Authors: Ledi Neçaj

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Objectives: The target of this paper is (1) to explain objectively physical activity model throughout three chronic cardiopulmonary conditions, and (2) to study the connection among physical activity dimensions with disease severity, self-reported physical and emotional functioning, and exercise performance. Material and Methods: This is a cross-sectional study of patients in their domestic environment. Patients with cardiopulmonary diseases were: chronic obstructive pulmonary disease (COPD), (n-63), coronary heart failure (n=60), and patients with implantable cardioverter defibrillator (n=60). Main results measures: Seven ambulatory physical activity dimensions (total steps, percentage time active, percentage time ambulating at low, medium, and hard intensity, maximum cadence for 30 non-stop minutes, and peak performance) have been measured with an accelerometer. Results: Subjects with COPD had the lowest amount of ambulatory physical activity compared with topics with coronary heart failure and cardiac dysrhythmias (all 7 interest dimensions, P<.05); total step counts have been: 5319 as opposed to 7464 as opposed to 9570, respectively. Six-minute walk distance becomes correlated (r=.44-.65, P<.01) with all physical activity dimensions inside the COPD pattern, the most powerful correlations being with total steps and peak performance. In topics with cardiac impairment, maximal oxygen intake had the most effective small to slight correlations with five of the physical activity dimensions (r=.22-.40, P<.05). In contrast, correlations among 6-minute walk test distance and physical activity have been higher (r=.48-.61, P<.01) albeit in a smaller pattern of most effective patients with coronary heart failure. For all three samples, self-reported physical and mental health functioning, age, frame mass index, airflow obstruction, and ejection fraction had both exceptionally small and no significant correlations with physical activity. Conclusions: Findings from this study present a profitable benchmark of physical activity patterns in individuals with cardiopulmonary diseases for comparison with future studies. All seven dimensions of ambulatory physical activity have disfavor between subjects with COPD, heart failure, and cardiac dysrhythmias. Depending on the research or clinical goal, the use of one dimension, such as total steps, may be sufficient. Although physical activity had high correlations with performance on a six-minute walk test relative to other variables, accelerometers-based physical activity monitoring provides unique, important information about real-world behavior in patients with cardiopulmonary not already captured with existing measures.

Keywords: ambulatory physical activity, walking, monitoring, COPD, heart failure, implantable defibrillator, exercise performance

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Authors: Kim Lytle, Tim Talty, Alan Michaels, Jeff Reed

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Implantable medical devices (IMDs) are medically necessary devices embedded in the human body that monitor chronic disorders or automatically deliver therapies. Most IMDs have wireless capabilities that allow them to share data with an offboard programming device to help medical providers monitor the patient’s health while giving the patient more insight into their condition. However, serious security concerns have arisen as researchers demonstrated these devices could be hacked to obtain sensitive information or harm the patient. Cooperative jamming can be used to prevent privileged information leaks by maintaining an adequate signal-to-noise ratio at the intended receiver while minimizing signal power elsewhere. This paper uses ray tracing to demonstrate how a low number of friendly nodes abiding by Bluetooth Low Energy (BLE) transmission regulations can enhance IMD communication security in an office environment, which in turn may inform how companies and individuals can protect their proprietary and personal information.

Keywords: implantable biomedical devices, communication system security, array signal processing, ray tracing

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Authors: Vitaliy Petrov, Natalia Shusharina, Vitaliy Kasymov, Maksim Patrushev, Evgeny Bogdanov

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The leading worldwide death reasons are ischemic heart disease and other cardiovascular illnesses. Generally, the common symptom is high blood pressure. Long-time blood pressure control is very important for the prophylaxis, correct diagnosis and timely therapy. Non-invasive methods which are based on Korotkoff sounds are impossible to apply often and for a long time. Implantable devices can combine longtime monitoring with high accuracy of measurements. The main purpose of this work is to create a real-time monitoring system for decreasing the death rate from cardiovascular diseases. These days implantable electronic devices began to play an important role in medicine. Usually implantable devices consist of a transmitter, powering which could be wireless with a special made battery and measurement circuit. Common problems in making implantable devices are short lifetime of the battery, big size and biocompatibility. In these work, blood pressure measure will be the focus because it’s one of the main symptoms of cardiovascular diseases. Our device will consist of three parts: the implantable pressure sensor, external transmitter and automated workstation in a hospital. The Implantable part of pressure sensors could be based on piezoresistive or capacitive technologies. Both sensors have some advantages and some limitations. The Developed circuit is based on a small capacitive sensor which is made of the technology of microelectromechanical systems (MEMS). The Capacitive sensor can provide high sensitivity, low power consumption and minimum hysteresis compared to the piezoresistive sensor. For this device, it was selected the oscillator-based circuit where frequency depends from the capacitance of sensor hence from capacitance one can calculate pressure. The external device (transmitter) used for wireless charging and signal transmission. Some implant devices for these applications are passive, the external device sends radio wave signal on internal LC circuit device. The external device gets reflected the signal from the implant and from a change of frequency is possible to calculate changing of capacitance and then blood pressure. However, this method has some disadvantages, such as the patient position dependence and static using. Developed implantable device doesn’t have these disadvantages and sends blood pressure data to the external part in real-time. The external device continuously sends information about blood pressure to hospital cloud service for analysis by a physician. Doctor’s automated workstation at the hospital also acts as a dashboard, which displays actual medical data of patients (which require attention) and stores it in cloud service. Usually, critical heart conditions occur few hours before heart attack but the device is able to send an alarm signal to the hospital for an early action of medical service. The system was tested with wireless charging and data transmission. These results can be used for ASIC design for MEMS pressure sensor.

Keywords: MEMS sensor, RF power, wireless data, oscillator-based circuit

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Authors: Mohamed Salah El-Din Mahmoud, Heba Radi Atta Allah

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Background: Our study assesses the safety profile and efficacy of toric Implantable Collamer Lens (T-ICL) and toric implantable phakic contact lens (IPCL) for the correction of high myopia with astigmatism. Methods: A prospective interventional randomized comparative study included 60 myopic eyes divided into 2 groups, group A including 30 eyes that were implanted with T-ICL, and group B including 30 eyes that were implanted with toric IPCL. The refractive results, visual acuity, corneal endothelial cell count, and intraocular pressure (IOP) were evaluated at baseline and at 1, 6, and 9 months post-surgery. Any complications either during or after surgery were assessed. Results: A significant reduction in both spherical and cylindrical refractive errors with good predictability was reported in both groups compared with preoperative values. Regarding the predictability, In T-ICL group (A), the median spherical and cylindrical errors were significantly improved from (-10 D & -4.5 D) pre-operatively to (-0.25 D & - 0.3 D) at the end of 9 months follow up period. Similarly, in the toric IPCL group (B), the median spherical and cylindrical errors were significantly improved from (-11 D & -4.5 D) pre-operatively to (-0.25 D & - 0.3 D) at the end of 9 months follow up period. A statistically significant improvement of UCDVA at 9 months postoperatively was found in both groups, as median preoperative Log Mar UCDVA was 1.1 and 1.3 in groups A and B respectively, which was significantly improved to 0.2 in both groups at the end of follow-up period. Regarding IOP, no significant difference was found between both groups, either pre-operatively or during the postoperative period. Regarding the endothelial count, no significant differences were found during the pre-operative and postoperative follow-up periods between the two groups. Fortunately, no intra or postoperative complications as cataract, keratitis or lens decentration had occurred. Conclusions: Toric IPCL is a suitable alternative to T-ICL for the management of high myopia with astigmatism, especially in developing countries, as it is cheaper and easier for implantation than T-ICL. However, data over longer follow-up periods are needed to confirm its safety and stability.

Keywords: T-ICL, Toric IPCL, IOP, corneal endothelium

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Authors: Puneet Goyal, Aarti Agarwal

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Background and Objective: Nutritional support is an integral part of palliative care of advanced non-resectable abdominal malignancy patients, though is frequently neglected aspect. Non-Healing high output Entero-cutaneous fistulas sometimes require long term parenteral nutrition, to take care of catabolism and replacement of nutrients. We present a case of inoperable pancreatic malignancy with high output entero-cutaneous fistula, which was provided parenteral nutritional support with the use of Totally Implantable Venous Access Device (TIVAD). Method and Results: 55 year old man diagnosed with carcinoma pancreas had developed high entero-cutaneous fistula. His tumor was found to be inoperable and was on total parenteral nutrition through routine central line. This line was difficult to maintain as he required it for a long term TPN. He was planned to undergo Totally Implantable Venous Access Device (TIVAD) implantation. 8Fr single lumen catheter with Groshong non-return Valve (Bard Access Systems, Inc. USA) was inserted through right internal jugular vein, under fluoroscopic guidance. The catheter was tunneled subcutaneously and brought towards infraclavicular pocket, cut at appropriate length and connected to port and locked. Port was sutured in floor of pocket. Free flow of blood aspirated, flushed with heparinized saline. There was no kink observed in entire length of catheter under fluoroscopy. Skin over infraclavicular pocket was sutured. Long term catheter care and associated risks were explained to patient and relatives. Patient continued to receive total parenteral nutrition as well as other supportive therapy though TIVAD for next 6 weeks, till his demise. Conclusion: TIVADs are standard of care for long term venous access solutions in cancer patients requiring chemotherapy. In this case, we extended its use for providing parenteral nutrition and other supportive therapy. TIVADs can be implanted in advanced cancer patients for providing venous access solution required for various palliative treatments and medications. This will help in improving quality of life and satisfaction amongst terminally ill cancer patients.

Keywords: parenteral nutrition, totally implantable venous access device, long term venous access, interventions in anesthesiology

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Authors: Werner Grommes

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Intelligent wearables (illuminated vests or hand and foot-bands, smart watches with a laser diode, Bluetooth smart glasses) overflow the market today. They are integrated with complex electronics and are worn very close to the body. Optical measurements and limitation of the maximum light density are needed. Smart watches are equipped with a laser diode or control different body currents. Special glasses generate readable text information that is received via radio transmission. Small high-performance batteries (lithium-ion/polymer) supply the electronics. All these products have been tested and evaluated for risk. These products must, for example, meet the requirements for electromagnetic compatibility as well as the requirements for electromagnetic fields affecting humans or implant wearers. Extensive analyses and measurements were carried out for this purpose. Many users are not aware of these risks. The result of this study should serve as a suggestion to do it better in the future or simply to point out these risks. Commercial LED warning vests, LED hand and foot-bands, illuminated surfaces with inverter (high voltage), flashlights, smart watches, and Bluetooth smart glasses were checked for risks. The luminance, the electromagnetic emissions in the low-frequency as well as in the high-frequency range, audible noises, and nervous flashing frequencies were checked by measurements and analyzed. Rechargeable lithium-ion or lithium-polymer batteries can burn or explode under special conditions like overheating, overcharging, deep discharge or using out of the temperature specification. Some risk analysis becomes necessary. The result of this study is that many smart wearables are worn very close to the body, and an extensive risk analysis becomes necessary. Wearers of active implants like a pacemaker or implantable cardiac defibrillator must be considered. If the wearable electronics include switching regulators or inverter circuits, active medical implants in the near field can be disturbed. A risk analysis is necessary.

Keywords: safety and hazards, electrical safety, EMC, EMF, active medical implants, optical radiation, illuminated warning vest, electric luminescent, hand and head lamps, LED, e-light, safety batteries, light density, optical glare effects

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Authors: Thomas Geninatti, Bruno Giacomo, Alessandro Grattoni

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Nanofluidic devices have been investigated for over a decade as promising platforms for the controlled release of therapeutics. The nanochannel drug delivery system (nDS), a membrane fabricated with high precision silicon techniques, capable of zero-order release of drugs by exploiting diffusion transport at the nanoscale originated from the interactions between molecules with nanochannel surfaces, showed the flexibility of the sustained release in vitro and in vivo, over periods of time ranging from weeks to months. To improve the implantable bio nanotechnology, in order to create a system that possesses the key features for achieve the suitable release of therapeutics, the next generation of nDS has been created. Platinum electrodes are integrated by e-beam deposition onto both surfaces of the membrane allowing low voltage (<2 V) and active temporal control of drug release through modulation of electrostatic potentials at the inlet and outlet of the membrane’s fluidic channels. Hence, a tunable administration of drugs is ensured from the nanochannel drug delivery system. The membrane will be incorporated into a peek implantable capsule, which will include drug reservoir, control hardware and RF system to allow suitable therapeutic regimens in real-time. Therefore, this new nanotechnology offers tremendous potential solutions to manage chronic disease such as cancer, heart disease, circadian dysfunction, pain and stress.

Keywords: nanochannel membrane, drug delivery, tunable release, personalized administration, nanoscale transport, biomems

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Authors: Natalie Riley, Anita Quigley, Robert M. I. Kapsa, George W. Greene

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As the fields of medicine and bionics grow rapidly in technological advancement, the future and success of it depends on the ability to effectively interface between the artificial and the biological worlds. The biggest obstacle when it comes to implantable, electronic medical devices, is maintaining a ‘clean’, low noise electrical connection that allows for efficient sharing of electrical information between the artificial and biological systems. Implant fouling occurs with the adhesion and accumulation of proteins and various cell types as a result of the immune response to protect itself from the foreign object, essentially forming an electrical insulation barrier that often leads to implant failure over time. Lubricin (LUB) functions as a major boundary lubricant in articular joints, a unique glycoprotein with impressive anti-adhesive properties that self-assembles to virtually any substrate to form a highly ordered, ‘telechelic’ polymer brush. LUB does not passivate electroactive surfaces which makes it ideal, along with its innate biocompatibility, as a coating for implantable bionic electrodes. It is the aim of the study to investigate LUB’s anti-fouling properties and its potential as a safe, bioinspired material for coating applications to enhance the performance and longevity of implantable medical devices as well as reducing the frequency of implant replacement surgeries. Native, bovine-derived LUB (N-LUB) and recombinant LUB (R-LUB) were applied to gold-coated mylar surfaces. Fibroblast, chondrocyte and neural cell types were cultured and grown on the coatings under both passive and electrically stimulated conditions to test the stability and anti-adhesive property of the LUB coating in the presence of an electric field. Lactate dehydrogenase (LDH) assays were conducted as a directly proportional cell population count on each surface along with immunofluorescent microscopy to visualize cells. One-way analysis of variance (ANOVA) with post-hoc Tukey’s test was used to test for statistical significance. Under both passive and electrically stimulated conditions, LUB significantly reduced cell attachment compared to bare gold. Comparing the two coating types, R-LUB reduced cell attachment significantly compared to its native counterpart. Immunofluorescent micrographs visually confirmed LUB’s antiadhesive property, R-LUB consistently demonstrating significantly less attached cells for both fibroblasts and chondrocytes. Preliminary results investigating neural cells have so far demonstrated that R-LUB has little effect on reducing neural cell attachment; the study is ongoing. Recombinant LUB coatings demonstrated impressive anti-adhesive properties, reducing cell attachment in fibroblasts and chondrocytes. These findings and the availability of recombinant LUB brings into question the results of previous experiments conducted using native-derived LUB, its potential not adequately represented nor realized due to unknown factors and impurities that warrant further study. R-LUB is stable and maintains its anti-fouling property under electrical stimulation, making it suitable for electroactive surfaces.

Keywords: anti-fouling, bioinspired, cell attachment, lubricin

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Authors: Meshandren Naidoo, Amy Gooden

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Implantable brain-computer interface (BCI) technologies have developed to the point where brain-computer communication is possible. This has great potential in the medical field, as it allows persons who have lost capacities. However, ethicists and regulators call for a strict approach to these technologies due to the impact on personhood. This research demonstrates that the personhood debate is more nuanced and that where an African approach to personhood is used, it may produce results more favorable to the development and use of this technology.

Keywords: artificial intelligence, law, neuroscience, ethics

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Authors: Ariba Siddiqui, Amber Khan

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The need for bio-implantable devices in the field of medical sciences has been increasing day by day; however, the charging of these devices is a major issue. Batteries, a very common method of powering the implants, have a limited lifetime and bulky nature. Therefore, as a replacement of batteries, acoustic power transfer (APT) technology is being accepted as the most suitable technique to wirelessly power the medical implants in the present scenario. The basic model of APT consists of piezoelectric transducers that work on the principle of converse piezoelectric effect at the transmitting end and direct piezoelectric effect at the receiving end. This paper provides mechanistic insight into the parameters affecting the design and efficient working of acoustic power transfer systems. The optimum design considerations have been presented that will help to compress the size of the device and augment the intensity of the pressure wave. A COMSOL model of the PZT (Lead Zirconate Titanate) transducer was developed. The model was simulated and analyzed on a frequency spectrum. The simulation results displayed that the efficiency of these devices is strongly dependent on the frequency of operation, and a wrong choice of the operating frequency leads to the high absorption of acoustic field inside the tissue (medium), poor power strength, and heavy transducers, which in effect influence the overall configuration of the acoustic systems. Considering all the tradeoffs, the simulations were performed again by determining an optimum frequency (900 kHz) that resulted in the reduction of the transducer's thickness to 1.96 mm and augmented the power strength with an intensity of 432 W/m². Thus, the results obtained after the second simulation contribute to lesser attenuation, lightweight systems, high power intensity, and also comply with safety limits provided by the U.S Food and Drug Administration (FDA). It was also found that the chosen operating frequency enhances the directivity of the acoustic wave at the receiver side.

Keywords: acoustic power, bio-implantable, COMSOL, Lead Zirconate Titanate, piezoelectric, transducer

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Authors: Kohji Mitsubayashi, Takahiro Arakawa, Kohji Mitsubayashi

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‘Cavitas sensors’ attached to human body cavities such as a contact lens type and a mouthguard (‘no implantable', ‘no wearable’) attracted attention as self-detachable devices for daily medicine. In this contribution, the soft contact lens glucose sensor for tear sugar monitoring will be introduced. And the mouthguard sensor with dental materials integrated with Bluetooth low energy (BLE) wireless module for real-time monitoring of saliva glucose would also be demonstrated. In the near future, those self-detachable cavitas sensors are expected to improve quality of life in view of the aging of society.

Keywords: cavitas sensor, biosensor, contact lens, mouthguard

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Authors: C. L Popa, C.S. Ciobanu, S. L. Iconaru, P. Chapon, A. Costescu, P. Le Coustumer, D. Predoi

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In this paper, the preparation and characterization of silver doped hydroxyapatite thin films and their antimicrobial activity characterized is reported. The resultant Ag: HAp films coated on commercially pure Si disks substrates were systematically characterized by Scanning Electron Microscopy (SEM) coupled with X-ray Energy Dispersive Spectroscopy detector (X-EDS), Glow Discharge Optical Emission Spectroscopy (GDOES) and Fourier Transform Infrared spectroscopy (FT-IR). GDOES measurements show that a substantial Ag content has been deposited in the films. The X-EDS and GDOES spectra revealed the presence of a material composed mainly of phosphate, calcium, oxygen, hydrogen and silver. The antimicrobial efficiency of Ag:HAp thin films against Escherichia coli and Staphylococcus aureus bacteria was demonstrated. Ag:HAp thin films could lead to a decrease of infections especially in the case of bone and dental implants by surface modification of implantable medical devices.

Keywords: silver, hydroxyapatite, thin films, GDOES, SEM, FTIR, antimicrobial effect

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Authors: Anders S. Kristensen, Dewan Ahsan, Saqib Mehmood, Shakeel Ahmed

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Traffic accidents are a result of the convergence of hazards, malfunctioning of vehicles and human negligence that have adverse economic and health impacts and effects. Unfortunately, avoiding them completely is very difficult, but with quick response to rescue and first aid, the mortality rate of inflicted persons can be reduced significantly. Smart and innovative technologies can play a pivotal role to respond faster to traffic crash emergencies comparing conventional means of transportation. For instance, Rescue Emergency Drone (RED) can provide faster and real-time crash site risk assessment to emergency medical services, thereby helping them to quickly and accurately assess a situation, dispatch the right equipment and assist bystanders to treat inflicted person properly. To conduct a research in this regard, the case of a traffic roundabout that is prone to frequent traffic accidents on the outskirts of Esbjerg, a town located on western coast of Denmark is hypothetically considered. Along with manual calculations, Emergency Disaster Management Simulation (EDMSIM) has been used to verify the response time of RED from a fire station of the town to the presumed crash site. The results of the study demonstrate the robustness of RED into emergency services to help save lives. 

Keywords: automated external defibrillator, medical emergency, response time, unmanned aerial system

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Authors: Chung-Yu Wu, Chia-Chi Chang, Wei-Ming Chen, Pu-Wei Wu, Shih-Fan Chen, Po-Chun Chen

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Electrostimulation medical devices for neural diseases require electroactive and biocompatible materials to transmit signals from electrodes to targeting tissues. Protection of surrounding tissues has become a great challenge for long-term implants. In this study, we designed back-end processes with compatible, efficient, and reliable advantages over the current state-of-the-art. We explored a hermetic packaging process with high quality of adhesion and uniformity as the biocompatible devices for long-term implantation. This approach is able to provide both excellent biocompatibility and protection to the biomedical electronic devices by performing conformal coating of biocompatible materials. We successfully developed a packaging process that is capable of exposing the stimulating electrode and cover all other faces of chip with high quality of protection to prevent leakage of devices and body fluid.

Keywords: biocompatible package, medical microelectronics, surface coating, long-term implantation

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Authors: Madhav Pant, Khem N. Poudel

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Wireless power transfer is continuously becoming more powerful and compact in medical implantable devices and the wide range of applications. A rectenna is designed for wireless power transfer technique that can be applied to medical implant devices. The experiment is performed using ANSYS HFSS, a full wave electromagnetic simulation. The dipole antenna combinations operating at 2.4 GHz are used for wireless power transfer and the maximum DC voltage reception by the implant considering International Commission on Non-Ionizing Radiation Protection (ICNIRP) regulation. The power receiving dipole antenna is placed inside the cylindrical geometry having the similar properties of the human body at the frequency of 2.4 GHz. Our design can provide the power at the depth of 5 mm skin and 5mm of bone for the implant. The voltage doubler/quadrupler rectifier in ANSYS Simplorer is used to calculate the exact DC current utilized by implant inside the human body. The qualitative design and analysis of this wireless power transfer method could also be used for other biomedical implants systems such as cardiac pacemaker, insulin pump, and retinal implants.

Keywords: dipole antenna, medical implants, wireless power transfer, rectifier

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Authors: Mona Elhelbawy, Mac Gray

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Traditional wired endoscopy is an intrusive process that requires a long flexible tube to be inserted through the patient’s mouth while intravenously sedated. Only images of the upper 4 feet of stomach, colon, and rectum can be captured, leaving the remaining 20 feet of small intestines. Wireless capsule endoscopy offers a painless, non-intrusive, efficient and effective alternative to traditional endoscopy. In wireless capsule endoscopy (WCE), ingestible vitamin-pill-shaped capsules with imaging capabilities, sensors, batteries, and antennas are designed to send images of the gastrointestinal (GI) tract in real time. In this paper, we investigate the radiation performance and specific absorption rate (SAR) of a miniature conformal capsule antenna operating at the Medical Implant Communication Service (MICS) frequency band in the human body. We perform numerical simulations using the finite element method based commercial software, high-frequency structure simulator (HFSS) and the ANSYS human body model (HBM). We also investigate the in-body channel characteristics between the implantable capsule and an external antenna placed on the surface of the human body.

Keywords: IEEE 802.15.6, MICS, SAR, WCE

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Authors: Maurice Ntahobari, Levin Kuhlmann, Mario Boley, Zhinoos Razavi Hesabi

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For machine learning based epileptic seizure prediction, it is important for the model to be implemented in small implantable or wearable devices that can be used to monitor epilepsy patients; however, current state-of-the-art methods are complex and computationally intensive. We use Shapley Additive Explanation (SHAP) to find relevant intracranial electroencephalogram (iEEG) features and improve the computational efficiency of a state-of-the-art seizure prediction method based on the extra trees classifier while maintaining prediction performance. Results for a small contest dataset and a much larger dataset with continuous recordings of up to 3 years per patient from 15 patients yield better than chance prediction performance (p < 0.004). Moreover, while the performance of the SHAP-based model is comparable to that of the benchmark, the overall training and prediction time of the model has been reduced by a factor of 1.83. It can also be noted that the feature called zero crossing value is the best EEG feature for seizure prediction. These results suggest state-of-the-art seizure prediction performance can be achieved using efficient methods based on optimal feature selection.

Keywords: machine learning, seizure prediction, extra tree classifier, SHAP, epilepsy

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Authors: J. Palán, M. Zemko

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COMTES FHT has been active in a field of research and development of high-strength wires for quite some time. The main material was pure titanium. The primary goal of this effort is to develop a continuous production process for ultrafine and nanostructured materials with the aid of severe plastic deformation (SPD). This article outlines mechanical and microstructural properties of the materials and the options available for testing the components made of these materials. Ti Grade 2 and Grade 4 wires are the key products of interest. Ti Grade 2 with ultrafine to nano-sized grain shows ultimate strength of up to 1050 MPa. Ti Grade 4 reaches ultimate strengths of up to 1250 MPa. These values are twice or three times as higher as those found in the unprocessed material. For those fields of medicine where implantable metallic materials are used, bulk ultrafine to nanostructured titanium is available. It is manufactured by SPD techniques. These processes leave the chemical properties of the initial material unchanged but markedly improve its final mechanical properties, in particular, the strength. Ultrafine to nanostructured titanium retains all the significant and, from the biological viewpoint, desirable properties that are important for its use in medicine, i.e. those properties which made pure titanium the preferred material also for dental implants.

Keywords: CONFORM, ECAP, rotary swaging, titanium

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Authors: M. M. Akhmediev, J. R. Ashrapov, T. M. Akhmediev

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Hydrocephalus frequently occurs with spina bifida, and up to 80% of such patients need to be shunted. Objective: It’s sought to improve the results of the surgical treatment of hydrocephalus in children with spina bifida. Methods: We have analyzed the results of the surgical treatment of 80 patients aged between 1 month and 1,5-year-old with hydrocephalus and myelomeningocele. All patients underwent surgery in the period of 2013-2018. Results: In all patients, spina bifida was associated with hydrocephalus with a predominant extension of the posterior horns of the lateral ventricles in the form of colpocephaly, Chiari malformation type 2. Based on the method “Choose right shunt” the determination of the point of critical deformation of the ventricular system was established, 47 (58.8%) patients for the 1st stage underwent ventriculoperitoneal (VP) shunt surgery with a low-pressure valve, 28 (35.0%) patients with medium pressure and 5 (6.2%) with high-pressure valve. Under or over drainage complications were not observed in the postoperative period. The 2nd stage of surgery for myelomeningocele repair was planned in 1-2 months with the follow-up head ultrasonography and electromyography study. Conclusion: The implantable shunt systems parameters chosen before surgery in the surgical management of hydrocephalus in children with myelomeningocele are important in the causes of under or over drainage states, cerebrospinal fluid leakage from the myelomeningocele sac. Management of hydrocephalus should be performed by considering myelomeningocele affecting craniospinal compliance.

Keywords: hydrocephalus, spina bifida, myelomeningocele, ventriculoperitoneal (VP) shunt

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Authors: Odaleia de O. Farias, Suzelene C. Marinho, Ecleidson B. Fragoso, Daniel S. Lima, Francisco R. S. Lira, Lara S. Araújo, Gabriel dos S. D. Soares

Abstract:

In populous cities, prehospital care services that use vehicles alternative to ambulances are needed in order to reduce costs and improve response time to occurrences in areas with large concentration of people, such as leisure and tourism spaces. In this context, it was implanted a program called BIKE VIDA, that is innovative quick access and assistance program. The aim of this study is to describe the implantation and initial profile of occurrences performed by an urgency/emergency pre-hospital care service through paramedics on bicycles. It is a cross-sectional, descriptive study carried out in the city of Fortaleza, Ceara, Brazil. The data included service records from July to August 2017. Ethical aspects were respected. The service covers a perimeter of 4.5 km, divided into three areas with perimeter of 1.5 km for each paramedic, attending from 5 am to 9 pm. Materials transported by bicycles include External Automated Defibrillator - DEA, portable oxygen, oximeter, cervical collar, stethoscope, sphygmomanometer, dressing and immobilization materials and personal protective equipment. Occurrences are requested directly by calling the emergency number 192 or through direct approach to the professional. In the first month of the program, there were 93 emergencies/urgencies, mainly in the daytime period (71,0%), in males (59,7%), in the age range of 26 to 45 years (46,2%). The main nature was traumatic incidents (53.3%). Most of the cases (88,2%) did not require ambulance transport to the hospital, and there were two deaths. Pre-hospital service through bicycles is an innovative strategy in Brazil and has shown to be promising in terms of reducing costs and improving the quality of the services offered.

Keywords: emergency, response time, prehospital care, urgency

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Authors: Yung-Shan Lu, Chia-Fone Lee, Shang-Hsuan Li, Chien-Hao Liu

Abstract:

Recently, various bioelectronic devices have been developed for neurologic disease treatments via electro-stimulations such as cochlear implants and retinal prosthesis. Since the electric signal needs electrodes to be transmitted to an organism, electrodes play an important role of stimulations. The materials of stimulation electrodes affect the efficiency of the delivered currents. The higher the efficiency of the electrodes, the lower the threshold current can be used to stimulate the organism which minimizes the potential damages to the adjacent tissues. In this study, we proposed a biocompatible composite electrode composed of high-charge-capacity iridium oxide (IrOₓ) film for a bone-guide extra-cochlear implant. IrOₓ was exploited to decrease the threshold current due to its high capacitance and low impedance. The IrOₓ electrode was fabricated via microelectromechanical systems (MEMS) photolithography and examined with in-vivo tests with guinea pigs. Based on the measured responses of brain waves to sound, the results demonstrated that IrOₓ electrodes have a lower threshold current compared with the Platinum (Pt) electrodes. The research results are expected to be beneficial for implantable and biocompatible electrodes for electrical stimulations.

Keywords: cochlear implants, electrode, electrical stimulation, iridium oxide

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Authors: Leszek Szpakowski, Daniel Celiński, Sławomir Pilip, Grzegorz Michalak

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The aim of the study was to analyse the usefulness of the 'E-rescuer' pilot project planned to be implemented in a chosen area of Eastern Poland in the cases of suspected sudden cardiac arrests in the extra-urban areas. Inventing an application allowing to dispatch simultaneously both Medical Emergency Teams and the E-rescuer to the place of the accident is the crucial assumption of the mentioned pilot project. The E-rescuer is defined to be the trained person able to take effective basic life support and to use automated external defibrillator. Having logged in using a smartphone, the E-rescuer's readiness is reported online to provide cardiopulmonary resuscitation exactly at the given location. Due to the accurately defined location of the E-rescuer, his arrival time is possible to be precisely fixed, and the substantive support through the displayed algorithms is capable of being provided as well. Having analysed the medical records in the years 2015-2016, cardiopulmonary resuscitation was considered to be effective when an early indication of circulation was provided, and the patient was taken to hospital. In the mentioned term, there were 2.291 cases of a sudden cardiac arrest. Cardiopulmonary resuscitation was taken in 621 patients in total including 205 people in the urban area and 416 in the extra-urban areas. The effectiveness of cardiopulmonary resuscitation in the extra-urban areas was much lower (33,8%) than in the urban (50,7%). The average ambulance arrival time was respectively longer in the extra-urban areas, and it was 12,3 minutes while in the urban area 3,3 minutes. There was no significant difference in the average age of studied patients - 62,5 and 64,8 years old. However, the average ambulance arrival time was 7,6 minutes for effective resuscitations and 10,5 minutes for ineffective ones. Hence, the ambulance arrival time is a crucial factor influencing on the effectiveness of cardiopulmonary resuscitation, especially in the extra-urban areas where it is much longer than in the urban. The key role of trained E-rescuers being nearby taking basic life support before the ambulance arrival can effectively support Emergency Medical Services System in Poland.

Keywords: basic life support, bystander, effectiveness, resuscitation

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Authors: Andreea Cârâc, Elena Morosan, Ana Corina Ionita, Rica Bosencu, Geta Carac

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Lanthanum carbonate exhibits a considerable ability to bind phosphate and the substitution of Ca2+ ions by divalent or trivalent lanthanide metal ions attracted attention during the past few years. Although Lanthanum carbonate has not been approved by the FDA for treatment of hyperphosphatemia, we prospectively evaluated the efficacy of the combination of Calcium hydroxyapatite and Lanthanum carbonate for the treatment of hyperphosphatemia on mice. Calcium hydroxyapatite commonly referred as CHAp is a bioceramic material and is one of the most important implantable materials due to its biocompatibility and osteoconductivity. We prepared calcium hydroxyapatite and lanthanum carbonate. CHAp was prepared by co-precipitation method using Ca(OH)2, H3PO4, NH4OH with calcination at 1200ºC. Lanthanum carbonate was prepared by chemical method using NaHCO3 and LaCl3 at low pH environment , ph below 4.0 The confirmation of both substances structures was made using XRD characterization, FTIR spectra and SEM /EDX analysis. The study group included 20 subjects-mice divided into four groups according to the administered substance: lanthanum carbonate (group A), lanthanum carbonate + CHAp (group B), CHAp (group C) and salt water (group D). The results indicate a phosphate decrease when subjects (mice) were treated with CHAp and lanthanum carbonate (0.5 % CMC), in a single dose of 1500 mg/kg. Serum phosphate concentration decreased [from 4.5 ± 0.8 mg/dL) to 4.05 ± 0.2 mg/dL), P < 0.01] in group A and to 3.6 ± 0.2 mg/dL] only after the 24 hours of combination therapy. The combination of CHAp and lanthanum carbonate is a suitable regimen for hyperphosphatemia treatment subjects because it avoids both the hypercalcemia of CaCO3 and the adverse effects of CHAp. The ability of CHAp to decrease the serum phosphate concentration is 1/3 that of lanthanum carbonate.

Keywords: calcium hydroxyapatite, hyperphosphatemia, lanthanum carbonate, phosphate, structures

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Authors: Sharda Nara, Bansi Dhar Malhotra

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Investigation of the vitamins as an electron transfer mediator could significantly assist in merging the area of tissue engineering and electronics required for the implantable therapeutic devices. The present study report that the molecules of folic acid released by Providencia rettgeri via fermentation route under the anoxic condition of the microbial fuel cell (MFC) exhibit characteristic electrochemical and optical properties, as indicated by absorption spectroscopy, photoluminescence (PL), and cyclic voltammetry studies. The absorption spectroscopy has depicted an absorption peak at 263 nm with a small bulge around 293 nm on day two of bacterial culture, whereas an additional peak was observed at 365 nm on the twentieth day. Furthermore, the PL spectra has indicated that the maximum emission occurred at various wavelengths 420, 425, 440, and 445 nm when excited by 310, 325, 350, and 365 nm. The change of emission spectra with varying excitation wavelength might be indicating the presence of tunable optical bands in the folic acid molecules co-related with the redox activity of the molecules. The results of cyclic voltammetry studies revealed that the oxidation and reduction occurred at 0.25V and 0.12V, respectively, indicating the electrochemical behavior of the folic acid. This could be inferred that the released folic acid molecules in a MFC might undergo inter as well as intra molecular electron transfer forming different intermediate states while transferring electrons to the electrode surface. Synchronization of electrochemical and optical properties of folic acid molecules could be potentially promising for the designing of electroactive scaffold and biocompatible conductive surface for the applications of tissue engineering and biofuel cells, respectively.

Keywords: biofuel cell, electroactivity, folic acid, tissue engineering

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Authors: Yan Yan, Erhong Sun, Lin Peng, Xuchun Ye

Abstract:

Aims: The present study aimed to explore Intensive Care Unit(ICU) nurses’ mental workload (MWL) and associated factors with it in performing human-machine tasks. Background: A wide range of emerging technologies have penetrated widely in the field of health care, and ICU nurses are facing a dramatic increase in nursing human-machine tasks. However, there is still a paucity of literature reporting on the general MWL of ICU nurses performing human-machine tasks and the associated influencing factors. Methods: A cross-sectional survey was employed. The data was collected from January to February 2021 from 9 tertiary hospitals in 6 provinces (Shanghai, Gansu, Guangdong, Liaoning, Shandong, and Hubei). Two-stage sampling was used to recruit eligible ICU nurses (n=427). The data were collected with an electronic questionnaire comprising sociodemographic characteristics and the measures of MWL, self-efficacy, system usability, and task difficulty. The univariate analysis, two-way analysis of variance(ANOVA), and a linear mixed model were used for data analysis. Results: Overall, the mental workload of ICU nurses in performing human-machine tasks was medium (score 52.04 on a 0-100 scale). Among the typical nursing human-machine tasks selected, the MWL of ICU nurses in completing first aid and life support tasks (‘Using a defibrillator to defibrillate’ and ‘Use of ventilator’) was significantly higher than others (p < .001). And ICU nurses’ MWL in performing human-machine tasks was also associated with age (p = .001), professional title (p = .002), years of working in ICU (p < .001), willingness to study emerging technology actively (p = .006), task difficulty (p < .001), and system usability (p < .001). Conclusion: The MWL of ICU nurses is at a moderate level in the context of a rapid increase in nursing human-machine tasks. However, there are significant differences in MWL when performing different types of human-machine tasks, and MWL can be influenced by a combination of factors. Nursing managers need to develop intervention strategies in multiple ways. Implications for practice: Multidimensional approaches are required to perform human-machine tasks better, including enhancing nurses' willingness to learn emerging technologies actively, developing training strategies that vary with tasks, and identifying obstacles in the process of human-machine system interaction.

Keywords: mental workload(MWL), nurse, ICU, human-machine, tasks, cross-sectional study, linear mixed model, China

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Authors: Yan Yan, Erhong Sun, Lin Peng, Xuchun Ye

Abstract:

Aims: The present study aimed to explore Intensive Care Unit (ICU) nurses’ mental workload (MWL) and associated factors with it in performing human-machine tasks. Background: A wide range of emerging technologies have penetrated widely in the field of health care, and ICU nurses are facing a dramatic increase in nursing human-machine tasks. However, there is still a paucity of literature reporting on the general MWL of ICU nurses performing human-machine tasks and the associated influencing factors. Methods: A cross-sectional survey was employed. The data was collected from January to February 2021 from 9 tertiary hospitals in 6 provinces (Shanghai, Gansu, Guangdong, Liaoning, Shandong, and Hubei). Two-stage sampling was used to recruit eligible ICU nurses (n=427). The data were collected with an electronic questionnaire comprising sociodemographic characteristics and the measures of MWL, self-efficacy, system usability, and task difficulty. The univariate analysis, two-way analysis of variance (ANOVA), and a linear mixed model were used for data analysis. Results: Overall, the mental workload of ICU nurses in performing human-machine tasks was medium (score 52.04 on a 0-100 scale). Among the typical nursing human-machine tasks selected, the MWL of ICU nurses in completing first aid and life support tasks (‘Using a defibrillator to defibrillate’ and ‘Use of ventilator’) was significantly higher than others (p < .001). And ICU nurses’ MWL in performing human-machine tasks was also associated with age (p = .001), professional title (p = .002), years of working in ICU (p < .001), willingness to study emerging technology actively (p = .006), task difficulty (p < .001), and system usability (p < .001). Conclusion: The MWL of ICU nurses is at a moderate level in the context of a rapid increase in nursing human-machine tasks. However, there are significant differences in MWL when performing different types of human-machine tasks, and MWL can be influenced by a combination of factors. Nursing managers need to develop intervention strategies in multiple ways. Implications for practice: Multidimensional approaches are required to perform human-machine tasks better, including enhancing nurses' willingness to learn emerging technologies actively, developing training strategies that vary with tasks, and identifying obstacles in the process of human-machine system interaction.

Keywords: mental workload, nurse, ICU, human-machine, tasks, cross-sectional study, linear mixed model, China

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Authors: Ghadah Abusalim, Suliman Alharbi, Hesham Khalil, Milton Wainwright, Mohammad A. Khiyami

Abstract:

The use of implantable foreign devices in medicine has recently increased dramatically. Intravascular cannulae and catheters are used to administer fluids, medications, parenteral nutrition, and blood products in order to monitor hemodynamic status and also to provide hemodialysis. The early and late failure of inserted or implanted devices is largely the result of bacterial infection and may lead to the disruption of integration between the device and the tissues which surround it. Staphylococcus aureus and Staphylococcus epidermidis are widely considered to be the most common organisms causing device-related infection. Our study showed that S. aureus and S. epidermidis adhered to intravascular cannulae made up of PTFE, SPTFE and vialon. Adhesion of S. epidermidis and S. aureus to intravascular cannulae varied significantly depending upon the type of material used and the presence of coating materials. Both bacteria adhered less to PTFE followed by Vialon and SPTFE and the adhesion capacity of S. aureus and S. epidermidis increased over time. Coating intravascular cannulae with human serum albumin inhibited the adhesion of S. aureus and S. epidermidis to these cannulae, and pretreatment of cannulae with fibronectin inhibited the adhesion of S. epidermidis but increased the adhesion of S. aureus to all types of cannulae. Pretreatment of cannulae surface with potassium chloride or calcium chloride increased the adhesion of S. aureus and S. epidermidis to cannulae, suggesting a role for electrostatic forces in the mechanism of such adhesion. This study will hopefully clarify the mechanism of adhesion and provide possible means of preventing such adhesion either by the use of better material coatings or by interfering with the process of adhesion by targeting bacterial structures responsible for it. Currently we recommend the use of PTFE cannulae as they exhibit a lower bacterial adhesion capacity compared to the other tested cannulae.

Keywords: Staphylococcus epidermidis, Staphylococcus aureus, adhesion, cannulae, PTFE, Vialon

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Authors: Victor Au, Khin Maung Than, Zaw Win Aung, Linawati Jumat

Abstract:

Background & Objectives: Cardiac arrests can occur anywhere or anytime, and most of the cases will be brought to the emergency department except the cases that happened in at in-patient setting. Raja IsteriPangiran Anak Saleha (RIPAS) Hospital is the only tertiary government hospital which located in Brunei Muara district and received all referral from other Brunei districts. Data of cardiac arrests in Brunei Darussalam scattered between Emergency Medical Ambulance Services (EMAS), Emergency Department (ED), general inpatient wards, and Intensive Care Unit (ICU). In this audit, we only focused on cardiac arrest cases which had happened or presented to the emergency department RIPAS Hospital. Theobjectives of this audit were to look at demographic of cardiac arrest cases and the survival to discharge rate of In-Hospital Cardiac Arrest (IHCA) and Out-Hospital Cardiac Arrest (OHCA). Methodology: This audit retrospective study was conducted on all cardiac arrest cases that underwent Cardiopulmonary Resuscitation (CPR) in ED RIPAS Hospital, Brunei Muara, in the year 2019-2020. All cardiac arrest cases that happened or were brought in to emergency department were included. All the relevant data were retrieved from ED visit registry book and electronic medical record “Bru-HIMS” with keyword diagnosis of “cardiac arrest”. Data were analyzed and tabulated using Excel software. Result: 313 cardiac arrests were recorded in the emergency department in year 2019-2020. 92% cases were categorized as OHCA, and the remaining 8% as IHCA. Majority of the cases were male with age between 50-60 years old. In OHCA subgroup, only 12.4% received bystander CPR, and 0.4% received Automatic External Defibrillator (AED) before emergency medical personnel arrived. Initial shockable rhythm in IHCA group accounted for 12% compare to 4.9% in OHCA group. Outcome of ED resuscitation, 32% of IHCA group achieved return of spontaneous circulation (ROSC) with a survival to discharge rate was 16%. For OHCA group, 12.35% achieved ROSC, but unfortunately, none of them survive till discharge. Conclusion: Standardized registry for cardiac arrest in the emergency department is required to provide valid baseline data to measure the quality and outcome of cardiac arrest. Zero survival rate for out hospital cardiac arrest is very concerning, and it might represent the significant breach in cardiac arrest chains of survival. Systematic prospective data collection is needed to identify contributing factors and to improve resuscitation outcome.

Keywords: cardiac arrest, OHCA, IHCA, resuscitation, emergency department

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