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혈관결찰기의 성능평가방법으로서 혈관파열압력시험의 유용성 연구

A Study on the Usability of the Vascular Bursting Pressure Test as a Method of Performance Evaluation of Vessel Sealing

Journal of Biomedical Engineering Research 2020년 41권 5호 p.210 ~ 218
강보람, 박아름, 김광택, 김선태, 이동혁,
소속 상세정보
강보람 ( Kang Bo-Ram ) - Gachon University GAIHST Department of Health Sciences and Technology
박아름 ( Park A-Reum ) - Gachon University GAIHST Department of Health Sciences and Technology
김광택 ( Kim Kwang-Taek ) - Gachon University College of Medicine
김선태 ( Kim Seon-Tae ) - Gachon University College of Medicine
이동혁 ( Lee Dong-Hyuk ) - Gachon University GAIHST Department of Health Sciences and Technology

Abstract


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.

키워드

Vessel; Sealing; Burst Pressure; regulation; medical device

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