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KMID : 1137820200410050210
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의공학회지
2020 Volume.41 No. 5 p.210 ~ p.218
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A Study on the Usability of the Vascular Bursting Pressure Test as a Method of Performance Evaluation of Vessel Sealing
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Kang Bo-Ram
Park A-Reum
Kim Kwang-Taek
Kim Seon-Tae
Lee Dong-Hyuk
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Abstract
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Vessel sealing is a medical device that converts electrical or ultrasonic energy into thermal energy and leads to seal, coagulate, and cut the vessel by protein modification within the walls or surrounding connective tissues. As most of surgeries have recently been conducted with minimally invasive surgery, the demand and market for vessel sealing are expected to get bigger. However, there is a problem that electrosurgical or ultrasonic surgical is applied and we have a high risk to evaluate the strength of seal, because the collateral and particular standards currently in force follows have not been establish. Therefore, in this study, we investigated some papers studied on the efficacy and safety of the device, the guidance of FDA and test papers previously conducted from 3 individual subject device made in Korea. We found there is a relationship between burst pressure and the performance of the device, therefore, we propose the vascular bursting pressure test for evaluating the safety and performance of the vessel sealing.
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KEYWORD
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Vessel, Sealing, Burst Pressure, regulation, medical device
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