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http://dx.doi.org/10.9718/JBER.2020.41.5.210

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

Kang, Bo Ram (Department of Health Sciences and Technology, GAIHST, Gachon University)
Park, A Reum (Department of Health Sciences and Technology, GAIHST, Gachon University)
Kim, Kwang Taek (College of Medicine, Gachon University)
Kim, Seon Tae (Department of Health Sciences and Technology, GAIHST, Gachon University)
Lee, Dong Hyuk (Department of Health Sciences and Technology, GAIHST, Gachon University)
Publication Information
Journal of Biomedical Engineering Research / v.41, no.5, 2020 , pp. 210-218 More about this Journal
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.
Keywords
Vessel; Sealing; Burst Pressure; regulation; medical device;
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1 PARK JB, et al. Effectiveness of the EnSeal (TM) System in Colorectal Cancer Surgery: A Pilot Randomized Study for Comparison with LigaSure (TM). J Minim Invasive Surg. 2013;16(3):39.   DOI
2 Ministry of Food and Drug Safety, 2018 Newly-opened Medical Device Forecast Analysis Report. 2018.
3 KENNEDY, J. S., et al. High-burst strength, feedback-controlled bipolar vessel sealing. Surgicalendoscopy. 1998;12(6):876-8.
4 LEE, Chang-Min; KANG, Dae-Young; KIM, Je-Ryong. A comparison of conventional thyroidectomy and LVSS thyroidectomy: The feasibility of the LVSS in the thyroid operation. Journal of the Korean Surgical Society. 2009;76(3):149-53.   DOI
5 MASSARWEH, Nader N.; COSGRIFF, Ned; SLAKEY, Douglas P. Electrosurgery: history, principles, and current and future uses. Journal of the American College of Surgeons. 2006;202(3):520-30.   DOI
6 FDA, Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery. 2016.
7 HAROLD, K. L., et al. 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. 2003;17(8):1228-30.   DOI
8 PERSON, Benjamin, et al. Comparison of four energy-based vascular sealing and cutting instruments: a porcine model. Surgical endoscopy. 2008;22(2):534-8.   DOI
9 NEWCOMB, William L., et al. Comparison of blood vessel sealing among new electrosurgical and ultrasonic devices. Surgical endoscopy. 2009;23(1):90-6.   DOI
10 YU, Jeong-Mi, et al. A Comparison of the Usefulness and Safety of the $Harmonic^{TM}$ Scalpel, $Ligasure^{TM}$ System, and Classic Clamp-and-Tie Technique for Hemostasis during Thyroid Surgery. Korean Journal of Endocrine Surgery. 2009;9(4):206-10.   DOI
11 SHIGEMURA, Norihisa; AKASHI, Akinori; NAKAGIRI, Tomoyuki. New operative method for a giant bulla: sutureless and stapleless thoracoscopic surgery using the Ligasure system. European journal of cardio - thoracic surgery. 2002;22(4):646-8.   DOI
12 DASKALOPOULOS, George, et al. Electrothermal bipolar coagulation for radical prostatectomies and cystectomies: a preliminary case-controlled study. International urology and nephrology. 2004;36(2):181-5.   DOI
13 TAMUSSINO, Karl, et al. Electrosurgical bipolar vessel sealing for radical abdominal hysterectomy. Gynecologic oncology. 2005;96(2):320-2.   DOI
14 DEO, S. V. S.; SHUKLA, N. K. Modified radical mastectomy using harmonic scalpel. Journal of surgical oncology. 2000;74(3):204-7.   DOI