• Title/Summary/Keyword: medical device

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Electron beam scattering device for FLASH preclinical studies with 6-MeV LINAC

  • Jeong, Dong Hyeok;Lee, Manwoo;Lim, Heuijin;Kang, Sang Koo;Lee, Sang Jin;Kim, Hee Chang;Lee, Kyohyun;Kim, Seung Heon;Lee, Dong Eun;Jang, Kyoung Won
    • Nuclear Engineering and Technology
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    • v.53 no.4
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    • pp.1289-1296
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    • 2021
  • In this study, an electron-scattering device was fabricated to practically use the ultra-high dose rate electron beams for the FLASH preclinical research in Dongnam Institute of Radiological and Medical Sciences. The Dongnam Institute of Radiological and Medical Sciences has been involved in the investigation of linear accelerators for preclinical research and has recently implemented FLASH electron beams. To determine the geometry of the scattering device for the FLASH preclinical research with a 6-MeV linear accelerator, the Monte Carlo N-particle transport code was exploited. By employing the fabricated scattering device, the off-axis and depth dose distributions were measured with radiochromic films. The generated mean energy of electron beams via the scattering device was 4.3 MeV, and the symmetry and flatness of the off-axis dose distribution were 0.11% and 2.33%, respectively. Finally, the doses per pulse were obtained as a function of the source to surface distance (SSD); the measured dose per pulse varied from 4.0 to 0.2 Gy/pulse at an SSD range of 20-90 cm. At an SSD of 30 cm with a 100-Hz repetition rate, the dose rate was 180 Gy/s, which is sufficient for the preclinical FLASH studies.

Development of Micro-Ceramic Heater for Medical Application (의료용 소형 세라믹스 히터 소자의 개발)

  • Lee, Seung-Min;Lee, Kwang-Ho
    • Journal of Biomedical Engineering Research
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    • v.43 no.4
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    • pp.219-229
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    • 2022
  • In this study, we propose a miniaturized micro-ceramic heater device. After screen-printing a silver paste between pre-sintered two aluminum oxide plates to integrate a heating circuit, the device was fabricated through a low-temperature sintering process. In order to configure the optimal heating circuit integration condition, the output current evaluation and heating test were performed according to the number of screen prints of the silver paste at various voltages. A silver paste-based heating circuit printed with a line width of 200 ㎛ and a thickness of 60 ㎛ was successfully integrated on a pre-sintered alumina substrate through a low-temperature sintering process. In the case of the 5 times printed device, the thermal response showed a response rate of 18.19 ℃/sec. To demonstrate feasibility of the proposed device in the medical field, such as bio-tissue suturing and hemostasis, a voltage was applied to pig tissue in the device to test tissue change due to heat generated from the device. These results show the possibility that the proposed small ceramic heater could be used in the medical field based on its excellent temperature response.

Comparative Study on the Definitions of "Home Medical Device" in Korea and in the Global Market (세계 시장과 한국에서의 "가정용 의료기기" 정의에 대한 비교연구)

  • Kim, Y.S.;Kang, H.K.;Park, S.
    • Journal of rehabilitation welfare engineering & assistive technology
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    • v.9 no.3
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    • pp.223-230
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    • 2015
  • There is an increasing trend of medical devices and products moving out of hospitals and clinics into community and residual homes for use by the general public due to both the technological developments and demographic changes resulted from the increased life expectancy and decreased birth rate. In Korea, however, the definition of "home medical device" is rather ambiguous and we thus compared the definition of the term used in the global market with that in Korea. FDA definition of "home medical device" includes the devices intended for use in both professional healthcare facilities and home. The KFDA, does not provide the definition for the "home medical device"and the definition has only been inferred from the results of consumer surveys. With a paradigm shift in advent of u-healthcare era, the definition of "home medical device" in Korea should include the medical devices that could be used both at hospitals and at home.

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Development of Numerical Model of Electrode for Radiofrequency Catheter Ablation Considering Saline Irrigation and Temperature-controlled Radiofrequency System (온도 조절형 고주파 시스템 및 식염수 분사를 고려한 전극도자절제술용 전극의 수치 모델 개발)

  • Ahn, Jin-Woo;Kim, Young-Jin;Lee, Seung-A;Jung, Ha-Chul;Kim, Kyung-Ah;Cha, Eun-Jong;Moon, Jin-Hee
    • Journal of Biomedical Engineering Research
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    • v.38 no.6
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    • pp.285-290
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    • 2017
  • Radiofrequency catheter ablation is the interventional therapy that be employed to eliminate cardiac tissue caused by arrhythmias. During radiofrequency catheter ablation, The thrombus can occur at electrode tip if the temperature of tissue and electrode is excess $100^{\circ}C$. To prevent this phenomenon, we investigated numerical model of electrode for radiofrequency catheter ablation considering saline irrigation and temperature-controlled radiofrequency system. The numerical model is based on coupled electric-thermal-flow problem and solved by COMSOL Multiphysics software. The results of the models show that the dimensions of the thermal lesion are increased if the flow rate of the saline irrigation and the set temperature are increased. The surface width characterized to determine the thermal lesion isn't need to measure in temperature-controlled radiofrequency system due to convective heat transfer by saline irrigation at tissue-electrode interface.

A Study on the Market of Imported Medical Devices in Myanmar

  • Bae, Hong Kyun
    • THE INTERNATIONAL COMMERCE & LAW REVIEW
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    • v.64
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    • pp.213-237
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    • 2014
  • The medical-device market of Myanmar in the recent Asian region is where the influences of Thailand, China, India and Singapore are being shown considerably with the lift-up of economic sanctions by America and the West. However, although the global capital and liberalization have widened the openness and the international concerns, the relative Myanmar's medical environment demands an active assistance and improvement. The study, recognizing the importance of Medical-Devices and their market conditions emerging as key business for knowledge-based industry, aims to obtain consequential meaningful suggestions, pursuant to relative export-concentration and sustainable market growth of Medical Devices, by analyzing inter-nation trade intensity for key Medical Device items. To do so, this study selected 8 nations in total by reviewing three points: core Medicine-advanced countries, geographically adjacent countries to Myanmar, and relative export-concentration.

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A Study on Regulatory Law for Management System of Combined Medical Device (결합 의료기기 관리제도의 규제관련 법률에 관한 연구)

  • Choi, Yong Jun;Choi, Mi Lim;Lee, Jeong Chan;Jung, Yong Gyu
    • Journal of Service Research and Studies
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    • v.4 no.2
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    • pp.1-10
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    • 2014
  • According to recent trends in technological advances and globalization, medical device industry may improve the constitution to meet worldwide medical equipment management system. Also it is holding a strand of mitigation to reach the level of international regulation. In addition, recent legislation tends are to stay limited ranges of industry regulations at least and take as open attitude for integration of new technologies combined medical devices. A greater environmental risk is not likely to work in medical technology, Combinded medical device is used as close to zero risk in most of the human body, which is classified as Class 1. Even medical device such as little or no risk in handling, it is possible to minimize the unnecessary administrative power and a waste of time to occur. For the medical device may be improving people's choices and access, medical equipment operator is expanding to include dealers, because this will be exalted to particular area of the business of the company. In this paper, we investigate the legal prerequisites for the establishment of a medical device. And propose improved regulations in topics in order to facilitate the repair and distribution markets for fair trade.

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Mechanical Properties of TiN and DLC coated Rod for Pedicle Screw System (TiN 및 DLC 코팅된 척추용 나사못 시스템 Rod의 기계적 특성 분석)

  • Kang, Kwan-Su;Jung, Tae-Gon;Yang, Jae-Woong;Woo, Su-Heon;Park, Tea-Hyun;Jeong, Yong-Hoon
    • Journal of the Korean institute of surface engineering
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    • v.50 no.3
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    • pp.183-191
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    • 2017
  • In this study, surface morphology and mechanical property of TiN and DLC coated pedicle screw have been investigated by field-emission scanning electron microscopy, energy dispersive X-ray spectroscopy, X-ray diffraction, vickers hardness test, axial gripping, and axial torsional gripping capacity test. From the EDS and XRD results, the composition and crystal structure of TiN and DLC coated surface were verified. The hardness value was increased by TIN and DLC coating, and the DLC coating surface has the highest value. The gripping capacity also showed higher value for TiN and DLC coated specimen than that of non-coated (Ti alloy) surface. The surface morphology of gripping tested specimen showed rougher scratched surface from Ti alloy than TiN and DLC coated layer.

The effects of circadian disturbances induced by night shifts on the mouse peripheral tissues

  • Seo, Dong-Hyun;Kim, Han-Sung;Ko, Chang-Yong;Schreiber, Jurgen;Jang, Yeong-Su;Bae, Kiho
    • Animal cells and systems
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    • v.16 no.5
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    • pp.357-365
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    • 2012
  • We have examined the effect of circadian disturbances induced by night shifts (NSs) on the phenotypes of the tibiae and abdominal adipose tissues (ADTs) in a mouse model by using in vivo micro-computed tomography (micro-CT). We found that the volumes of total and visceral ADTs in the night-shifted group of mice were significantly larger (69 and 92%, respectively) than those in the control. The mean polar moment of inertia, cross-sectional thickness, and bone mineral density of the cortical bone in the night-shifted group of mice were less (13, 5, and 3%, respectively) than those in the control. Moreover, the volume and the thickness of growth plates (GPs) of the tibiae in the night-shifted mice were significantly smaller (22 and 20%, respectively) than those in the control. Taken together, our results indicate that disturbances in the mouse circadian rhythms induced by NSs affect the morphological characteristics of cortical bone, the volume and the thickness of GPs, and the volume of ADTs.

Efficacy evaluation of syringe pump developed for continuous drug infusion

  • Jung, Bongsu;Seo, Kwang-Suk;Kwon, Suk Jin;Lee, Kiyoung;Hong, Suyong;Seo, Hyounsoon;Kim, Gi-Young;Park, Geun-Mook;Jeong, Juhee;Seo, Soowon
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.16 no.4
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    • pp.303-307
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    • 2016
  • Background: In dental intravenous sedation, continuous intravenous infusion of a low-dose drug requires an infusion pump such as a syringe pump. To develop a new syringe pump for clinical use, the functions of the pump must meet certain international standards. Various safety and efficacy tests must be performed on the syringe pump, as stipulated by these standards, and an approval must be received from the approving agency based on such test results. Methods: The authors of the present study developed a novel syringe pump and performed efficacy evaluation by testing its infusion speed at 1 and 25 ml/h, and infusion performance testing at 2 and 24 h. Moreover, performance evaluation was conducted by comparing the novel pump to an existing pump with the infusion speed varied from 1 to 5 ml/h. Results: In the efficacy testing on the newly developed syringe pump, infusion with the infusion speed initially set to 1 ml/h resulted in infusion speeds of 1.00 and 0.99 ml/h in the 2- and 24-h assessment, respectively. Changing the infusion speed setting to 25 ml/h resulted in an infusion speed of 25.09 and 23.92 ml/h in the 2- and 24-h assessment, respectively. These results show no significant differences when compared with other commercially available pumps. Conclusions: The efficacy testing of the newly developed syringe pump showed the accuracy to be within tolerance. Based on these findings, we believe that the newly developed syringe pump is suitable for clinical use.

The Effects of Partial Vibration on Tibia of Osteoporosis Induced Rat (골다공증이 유발된 쥐 정강이뼈에 적용한 부분 진동자극 효과)

  • Park, Ji-Hyung;Seo, Dong-Hyun;Jung, Young-Jin;Ko, Chang-Yong;Kim, Han-Sung
    • Journal of the Korean Society for Precision Engineering
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    • v.29 no.5
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    • pp.578-583
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    • 2012
  • The pharmacological therapies and whole body vibration as non-pharmacological therapies were known to have adverse side effects. Therefore, partial stimulation was suggested and its effects were evaluated. This study aimed to evaluate the site-specific effects of partial stimulator for treatment of osteoporosis induced by estrogen deficiency. Sixteen virginal Sprague-Dawley rats (12 weeks old) were divided into 2 groups(no stimulation, stimulation groups). All rats were ovariectomised to induce osteoporosis. After 3 weeks of operation, the right tibiae in rats of stimulation group (frequency: 10Hz, cycle: 1500, strain on bone surface: $2000{\mu}{\varepsilon}$) were stimulated perpendicularly at right tibia by using partial stimulator for 6 weeks (3days/week). The right tibiae in rats were scanned, before stimulation (0 week) and at 6 weeks after stimulation by using in-vivo micro computed tomography. For investigation of changes in morphological characteristics, structural parameters were measured and calculated. At 6 weeks the morphological characteristics (relative value) in stimulation group were significantly enhanced than those in no stimulation group (p<0.05). In this study, we find that after 6 weeks of partial stimulation, the morphological characteristics of tibia trabecular bone were enhanced. Thus, we concluded that partial stimulation could be used to treat osteoporosis.