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
1
조회
0
다운로드
2
인용
0
참고문헌
키워드
초록
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.
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.
참고문헌 (14)
- PARK JB, "Effectiveness of the EnSeal (TM) System in Colorectal Cancer Surgery: A Pilot Randomized Study for Comparison with LigaSure (TM)", J Minim Invasive Surg, 16(3), pp.39~ (2013)
- 2018 Newly-opened Medical Device Forecast Analysis Report, "Ministry of Food and Drug Safety", ~ (2018)
- KENNEDY, J. S., "High-burst strength, feedback-controlled bipolar vessel sealing", Surgicalendoscopy, 12(6), pp.876~878 (1998)
- 이창민, "전통적 갑상선 절제술과 LVSS 갑상선 절제술의 비교: 갑상선 수술에서 리가슈어 혈관 결찰 기구의 편리성", Annals of Surgical Treatment and Research, 76(3), pp.149~153 (2009), 대한외과학회
- MASSARWEH, Nader N., "Electrosurgery: history, principles, and current and future uses", Journal of the American College of 5Surgeons, 202(3), pp.520~530 (2006)
- FDA, "Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery", ~ (2016)
- HAROLD, K. L., "Comparison of ultrasonic energy, bipolar thermal energy, and vascular clips for the hemostasis of small-, medium-, and large-sized arteries", Surgical Endoscopy And Other Interventional Techniques, 17(8), pp.1228~1230 (2003)
- PERSON, Benjamin, "Comparison of four energy-based vascular sealing and cutting instruments: a porcine model", Surgical endoscopy, 22(2), pp.534~538 (2008)
- NEWCOMB, William L., "Comparison of blood vessel sealing among new electrosurgical and ultrasonic devices", Surgical endoscopy, 23(1), pp.90~96 (2009)
- YU, Jeong-Mi, "A Comparison of the Usefulness and Safety of the HarmonicTM Scalpel, LigasureTM System, and Classic Clamp-and-Tie Technique for Hemostasis during Thyroid Surgery", Korean Journal of Endocrine Surgery, 9(4), pp.206~210 (2009)
- SHIGEMURA, Norihisa, "New operative method for a giant bulla: sutureless and stapleless thoracoscopic surgery using the Ligasure system", European journal of cardio-thoracic surgery, 22(4), pp.646~648 (2002)
- DASKALOPOULOS, George, "Electrothermal bipolar coagulation for radical prostatectomies and cystectomies: a preliminary case-controlled study", International urology and nephrology, 36(2), pp.181~185 (2004)
- TAMUSSINO, Karl, "Electrosurgical bipolar vessel sealing for radical abdominal hysterectomy", Gynecologic oncology, 96(2), pp.320~322 (2005)
- DEO, S. V. S., "Modified radical mastectomy using harmonic scalpel", Journal of surgical oncology, 74(3), pp.204~207 (2000)