• Journal of Korea Multimedia Society
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• v.22 no.11
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• pp.1280-1287
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• 2019

For developing a wireless implantable device to monitoring the artery variation in real-time. The concept of a special vessel variation measurement capacitive sensor is presented in this paper. The sensor consists of two part; main sensor to measuring the arterial variation, and reference sensor is used to improve the accuracy of the capacitance value variation. Before sensor manufacture, a model of the sensor attached on the artery was designed in 3D to conduct in the FEA simulation to validate the validity and feasibility of the idea. The artery model was designed as layered structures and made of collagenous soft tissues with intima inside, followed by the media and the adventitia. Also, a grease layer was designed in the inner of the arterial wall to imitate the clogged arteries. The simulation was divided into two parts; sensor performance test by changing the diameter of the grease layer, and arterial wall tension test by changing the blood pressure. As the simulation results, the capacitance value measured by the proposed sensor is decreased follow the diameter of the grease increased. Also, large elastic deformation of the arterial wall since changing the blood pressure has been observed.

• Journal of Biomedical Engineering Research
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• v.44 no.1
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• pp.1-10
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• 2023

With the announcement of MEDICAL DEVICE REGULATION 2017/745 (MDR) on April 5 2017, medical device manufacturers shall apply ISO 14971:2019 (3^rd) revised in December 2019. However, there is not much related information and guidance available to medical device manufacturers, especially single use medical device. Risk management process basically follow 5 steps which are Risk Analysis, Risk Evaluation, Risk Control, Evaluation of overall residual risk and post-production activities. The purpose of this study is to provide a guidance of from risk analysis with Failure Mode and Effects Analysis (FMEA) table to overall residual risk evaluation for the single use medical device and to reflect it in a Periodic Safety Update Reports (PSUR) to satisfy with MDR requirements with single use medical device which are widely used and manufactured FDA class 2 or CE class IIb as examples. For this study, single use medical device manufacturer can adopt ISO 14971:2019 in accordance with MDR requirements and it can be extended to the PSUR. But there are still limitations to adopt to the all-single use medical device especially high class, private device and implantable device. So, Competent Authority (CA) shall publish more guidance for the single use medical device.

• Journal of Semiconductor Engineering
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• v.1 no.1
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• pp.46-56
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• 2020

This article highlights new opportunities of inorganic semiconductor materials for bio-implantable electronics, as a subset of 'transient' technology defined by an ability to physically dissolve, chemically degrade, or disintegrate in a controlled manner. Concepts of foundational materials for this area of technology with historical background start with the dissolution chemistry and reaction kinetics associated with hydrolysis of nanoscale silicon surface as a function of temperature and pH level. The following section covers biocompatibility of silicon, including related other semiconductor materials. Recent transient demonstrations of components and device levels for bioresorbable implantation enable the future direction of the transient electronics, as temporary implanters and other medical devices that provide important diagnosis and precisely personalized therapies. A final section outlines recent bioresorbable applications for sensing various biophysical parameters, monitoring electrophysiological activities, and delivering therapeutic signals in a programmed manner.

• Journal of Chest Surgery
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• v.35 no.7
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• pp.548-552
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• 2002

Korean artificial heart(AnyHeart) is a single-pieced and implantable hi-ventricular pulsaile pump adapting a moving actuator mechanism. The authors report a case of clinical application of AnyHeart as a life-saving device for the patients with end-stage heart disease combined with biventricular failure.

• Journal of the Institute of Electronics and Information Engineers
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• v.52 no.1
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• pp.148-154
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• 2015

Reports show that global system for mobile communication (GSM) mobile phones, or two-generation (2G) mobile phones, could affect functions of pacemakers and implantable cardioverter defibrillators (ICDs). In this study, we evaluated the effects of radio frequency electromagnetic fields (RF-EMFs) emitted by wideband code division multiple access (WCDMA) mobile phones, which were third-generation (3G) mobile phones, on pacemakers and ICDs. Five pacemakers and three ICDs were subjected to in-vitro test using a ECG simulator. We used a WCDMA module (average power : 0.25 W, frequency band : 1950 MHz) instead of a real WCDMA mobile phone. To assess the effects of the WCDMA module on pacemakers and ICDs, each implantable device was placed in close proximity (within 3 mm) to the WCDMA module for 5 min. As a result, no effects were observed on the five pacemakers and three ICDs for the RF-EMFs emitted by the WCDMA module. Because WCDMA mobile phones have the higher frequency band (1800-2200 MHz) and lower power output (0.01-0.25 W) than GSM moboile phone, the RF-EMFs emitted by WCDMA mobile phones do not affect patients with pacemaker or ICD.

• Journal of Biomedical Engineering Research
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• v.22 no.5
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• pp.439-448
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• 2001

This paper considers the acoustical characteristics of the closing click sounds of the mechanical valves employed in an implantable biventricular assist device (BYAD) and their re1evance to the Physical states of the valved. Bj rk Shiley Convexo Concave tilting disk valve was chosen for the study and acoustic measurement was made for the BYAD operated in a mock circulatory system as well as implanted in an animal (sheep). In the BYAD operated in the mock circulatory system. three different states of the valve were examined, ie. normal. mechanically damaged. pseudo-thrombus attached. Microphone measurement for the BVAD implanted in the animal was carried out for five days at a regular time interval from one day after implantation. Characteristic spectrum of the sound from the valve was estimated using Multiple Signal Classification (MUSIC) in which the optimal order was determined according to Bayesian Information Criterion (BIC) . It was observed that the mechanical damage of the valve resulted in changes of the structure of the acoustic spectrum. In contrast. the thrombus formed on the valve did not change much the basic structure of the spectrum but brought about altering the spectral Peak frequencies and energies. Maximum spectral Peak (MSP) with the greatest energy was seen at 2 kHz for the normal valve and it was shifted to 3 kHz for the calve attaching the Pseudo-thrombus. Unlike the normal valve, strong spectral Peak appeared around 7 kHz in the sound from the valve mechanically damaged. In the case of the BYAD implanted in the animal. as the thrombus grew, acoustic energy was reduced relatively more in the low frequency components (〈 2 kHz) and the frequencies of the 1st, 2nd and 3rd MSP were increased little. The thrombus formation would result in reduction in both the variability of the 1st, 2nd and 3rd MSP and the value of the BIC optimal order.

• Journal of the Microelectronics and Packaging Society
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• v.28 no.2
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• pp.13-28
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• 2021

Since transient electronic devices can operate under harsh conditions such as electrolytic solutions or inside the body, and be removed by hydrolysis after operation, they can replace conventional electronic devices in various research areas like biomedical implantable devices. Moreover, transient electronic devices that can dissolve in water and enzymes are the focus of the new concept of green technology, which can solve electrical waste issues. However, the surroundings of transient electronic devices can deteriorate internal device components. Thus, an encapsulation strategy is introduced for stable operation in solution by shielding the outside of a device with a passive barrier. This article summarizes recent research trends in transient electronic devices, including their background, dissolution behavior, and encapsulation strategies to enhance reliability by blocking water permeation.

• Journal of Sensor Science and Technology
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• v.18 no.4
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• pp.286-293
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• 2009

The implantable middle ear hearing devices(IMEHDs) have been developed to overcome the conventional hearing aid's problem(ringing effect caused by the acoustic feedback, cosmetic problem, etc.). In the IMEHDs, the vibrating transducer is a key component because its vibration enables to hear for hearing impaired people. The vibrating transducer is implanted on ossicular chain by surgical operation. The coupling status between implanted transducer and ossicular chain has an effect on delivering vibrating force from transducer to stapes. Noninvasive method is required to investigate the output characteristics of IMEHDs after implementation. Recently, emitted sound pressure measuring method of tympanic membrane is proposed to investigate the output characteristics of IMEHDs. However, the relationship between displacement of stapes and sound pressure by tympanic membrane was not cleared. In this paper, displacement of stapes and sound pressure by tympanic membrane were measured using the differential floating mass transducer(DFMT) that implanted on the ossicular chain of the human temporal bone and physical ear model. Through the experiments results, the relationship between displacement of stapes and sound pressure by tympanic membrane was investigated.

• Journal of the Korean institute of surface engineering
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• v.55 no.6
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• pp.390-397
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• 2022

Parylene-C which was mainly used for industries such as electronics, machinery and semiconductors has recently been in the spotlight in the medical field due to its properties such as corrosion resistance and biocompatibility. In this study we intend to derive a plan to improve the bonding strength of Parylene-C coating with the SUS304 base material for medical use which can be applied to various medical fields such as needles, micro needles and in vitro diagnostic device sensors. Through plasma pretreatment the bonding strength between Parylene-C and metal materials was improved. It was confirmed that the coated surface was hydrophobic by measuring the contact angle and the improvement of the surface roughness of the sample manufactured through CNC machining was confirmed by measuring the surface roughness with SEM. Through the above results, it is thought that it will be effective in increasing usability and reducing pain in patients by minimizing friction when inserting medical devices and in contact with skin. In addition it can be applied to various application fields such as human implantable stents and catheters, and is expected to improve the performance and lifespan of medical parts.

• Journal of Biomedical Engineering Research
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• v.18 no.4
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• pp.429-438
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• 1997

Mechanical valve is one of the most widely used implantable artificial organs of which the reliability is so important that its failure means the death of patient. Therefore early noninvasive detection is essentially required, though mechanical valve failure with thrombosis is the most common. The objective of this paper is to detect the thrombosis formation by spectral analysis and neural network. Using microphone and amplifier, we measured the sound from the mechanical valve which is attached to the pneumatic ventricular assist device. The sound was sampled by A/D converter(DaqBook 100) and the periodogram is the main algorithm for obtaining spectrum. We made the thrombosis models using pellethane and silicon and they are thrombosis model on the valvular disk, around the sewing ring and fibrous tissue growth across the orifice of valve. The performance of the measurment system was tested firstly using 1 KHz sinusoidal wave. The measurement system detected well 1KHz spectrum as expected. The spectrum of normal and 5 kinds of thrombotic valve were obtained and primary and secondary peak appeared in each spectrum waveform. We find that the secondary peak changes according to the thrombosis model. So to distinguish the secondary peak of normal and thrombotic valve quantatively, 3 layer back propagation neural network, which contains 7, 000 input node, 20 hidden layer and 1 output was employed The trained neural network can distinguish normal and valve with more than 90% probability. As a conclusion, the noninvasive monitoring of implanted mechanical valve is possible by analysing the acoustical spectrum using neural network algorithm and this method will be applied to the performance evaluation of other implantable artificial organs.