국립 부경대학교

부경대, 담관 협착증 내시경 레이저 치료법 개발
- 의공학과 연구팀, 의료기기 임상시험계획 승인 획득

△ 강현욱 교수(왼쪽)와 트루옹 연구원. ⓒ사진 이성재(대외홍보팀)

국립부경대학교(총장 장영수) 의공학과 연구팀이 담관 협착증 치료 시 회복기간을 줄이고 비용을 절감할 수 있는 새로운 내시경 레이저 치료법을 개발해 주목받고 있다.

부경대는 의공학과 강현욱 교수와 4차산업융합바이오닉스공학과 트루옹 반 지아 연구원(박사수료)이 내시경을 기반으로 한 새로운 레이저 치료기술을 개발해 식품의약품안전처(KFDA)로부터 3등급 의료기기 임상시험계획(IND)을 승인받았다고 밝혔다.

3등급 의료기기는 인체 내에 일정 기간 삽입되어 사용되거나 잠재적 위험성이 높은 의료기기로 분류되며, 임상시험계획 승인은 연구실 수준이 아닌 의료기기 상용화를 위한 임상시험을 본격화한다는 의미다.

담관 협착증은 쓸개즙이 배출되지 않아 영양실조, 황달 등의 증상을 보이며 조기사망 위험이 매우 큰 질환이다. 현재 스텐트를 삽관하는 내시경역행담췌관조영술(ERCP)로 치료하지만, 6개월마다 스텐트 교환이 필요하고 스텐트 이동과 폐색 문제로 시술이 잦고 비용부담도 큰 한계가 있다.

연구팀이 이번에 개발한 레이저 치료기술은 광섬유와 카테터가 융합된 광 전달기기(BCDA)를 이용, 담관 내벽에 레이저 빛을 균일하게 전달해 비접촉 열 치료를 진행하고, 동시에 카테터로 협착 조직을 확장하는 효과적인 내시경 기반 국소치료법이다.

전임상 시험결과 균일한 조직 확장 치료로 치료 유효성이 확인됐고, 염증 반응, 천공 등 합병증 최소화로 초기 안전성도 확보됐다. 연구팀은 이 기술을 적용하면 회복 기간 단축으로 환자들의 삶의 질 향상과 사회경제적 비용 절감도 가능할 것으로 기대하고 있다.

이번 연구는 보건의료기술연구개발사업(주관 인하대병원 정석 교수)과 한국연구재단 중점연구소지원사업(주관 부경대 정원교 교수)의 지원을 받아 진행됐다. 연구팀은 의료기기 제조 전문기업 블루코어컴퍼니를 주관으로 임상시험계획을 승인받았고, 이를 기반으로 내년부터 임상시험을 진행할 예정이다.

한편 부경대 의공학과 강현욱 교수 연구팀은 내시경 기반 레이저 치료법의 상용화를 진행 중이다. 좁은 췌담도내시경 내부에서도 사용될 수 있는 새로운 소형 융합 광 전달기기를 개발하며 4건의 국내외 특허 등록 및 6건의 SCI급 논문을 출판했다. 연구팀의 트루옹 연구원은 이번 연구 내용으로 최근 열린 국제학술대회 SPIE-ABC 2021에서 Young Investigator Award를 수상하기도 했다. <부경투데이>

△ 광 전달기기(BCDA)를 이용한 내시경 기반 레이저 치료법 표현 이미지.

PKNU newly developed an endoscopic laser treatment of biliary stricture

- A research team of the Biomedical Engineering Department obtained an approval on clinical test plan for the medical device

A research team from the Department of Biomedical Engineering at Pukyong National University (President Jang Young-Soo) has developed a new endoscopic laser treatment that can shorten the recovery period and reduce costs in the treatment of biliary stricture, drawing attention from the academic community.

Pukyong National University has announced that Professor Kang Hyun-Wook of the Department of Biomedical Engineering and Researcher Van Gia Truong, who completed a doctorate in the Department of Industry 4.0 Convergence Bionics Engineering, developed a new laser treatment technology based on an endoscope and conducted a clinical trial and it has been approved of a class 3 medical device trial plan (IND) by the Korea Food and Drug Administration.

A Class 3 medical device is classified as a medical device that can be inserted into the human body for a certain period of time or has a high potential risk, therefore, the approval of the clinical trial plan for this device means that clinical trials for commercialization of medical devices will be accelerated, not at the laboratory level.

This stricture of bile duct is a disease with a high risk of early death, with symptoms such as malnutrition and jaundice due to the biliary drainage inability. Currently, this is treated with endoscopic retrograde cholangio-pancreatography (ERCP), which is intubated with a stent, but there are limitations in that the stent needs to be replaced every 6 months, and the procedure is frequent and expensive due to problems with stent movement and blockages.

The laser treatment technology developed by the research team is an effective endoscopy-based local therapy using a light delivery device (BCDA) fused with an optical fiber and a catheter to uniformly deliver laser light to the inner wall of the bile duct to perform contact-free thermotherapy, while at the same time expanding the stenosed tissue with a catheter.

As a result of preclinical testing, treatment efficacy has been confirmed with uniform tissue expansion treatment, and initial stability has been also secured by minimizing complications such as inflammatory reaction and perforation. The research team expects that by applying this technology, it will be possible to improve the quality patient's life and reduce socio-economic costs by shortening the recovery period.

The research was carried out with support from the Health and Medical Technology R&D Project (hosted by Prof. Jeong Seok of Inha University Hospital) and the National Research Foundation's Key Research Center Support Project (hosted by Professor Jeong Won-Kyo, Pukyong National University). The research team received approval for a clinical test plan hosted by Bluecore Company Co., Ltd., a company specializing in medical device manufacturing, and plans to conduct clinical trials from next year based on this.

Currently, Professor Kang Hyun-Wook's research team at Pukyong National University's Department of Biomedical Engineering is dedicated to the commercialization of endoscopic-based laser therapy. They developed a new compact fusion light transmission device that can be used inside a narrow pancreas and biliary tract endoscopy, and have registered 4 domestic and international patents and published 6 SCI-level papers. Researcher Van Gia Truong of the research team was awarded the Young Investigator Award at the recent international conference SPIE-ABC 2021 for this research. <Pukyong Today>