초록 ▼

에크모(ECMO)는 인공 폐와 혈액펌프를 통해 환자의 혈액에 산소 공급한 후 체내에 넣어주는 의료장비로서 중증의 심폐부전 환자치료와 이식수술에 필수인바 장비와 재료 모두 수입에 의존해 큰 비용 부담이 있는 4등급 의료기기입니다.

ECMO의 국산화 위해 분당서울대병원, 서울대학교 의과대학, 서강대학교, 서울아산병원 공동연구팀이 ㈜세비카와 공동으로 2019년 10월 최종적으로 국산 “스마트 올인원 심폐순환 보조장치 시스템” 시제품을 완성하고 식품의약품안전처로부터 신개발 의료기기에 대한 탐색적 임상시험 허가를 득하여 폐 이식

에크모(ECMO)는 인공 폐와 혈액펌프를 통해 환자의 혈액에 산소 공급한 후 체내에 넣어주는 의료장비로서 중증의 심폐부전 환자치료와 이식수술에 필수인바 장비와 재료 모두 수입에 의존해 큰 비용 부담이 있는 4등급 의료기기입니다.

ECMO의 국산화 위해 분당서울대병원, 서울대학교 의과대학, 서강대학교, 서울아산병원 공동연구팀이 ㈜세비카와 공동으로 2019년 10월 최종적으로 국산 “스마트 올인원 심폐순환 보조장치 시스템” 시제품을 완성하고 식품의약품안전처로부터 신개발 의료기기에 대한 탐색적 임상시험 허가를 득하여 폐 이식 환자 수술에 성공적으로 적용하였습니다.

연구진에 의한 성공적인 제품 개발 및 임상적용, 그리고 임상시험에 대한 복지부/보건산업진흥원 및 식품의약품안전처의 지원으로 정부지원 연구개발의 모범 사례가 되었으며 전체 시스템의 국산화율 향상 및 본격적인 4등급 의료기기 국산화 시대를 열 것으로 기대됩니다.

(출처 : 요약서 3p)

Abstract ▼

< R&D Goal >
Final Goal:a multi-purpose cardiopulmonary circulatory assistive device that can be used for various indications is to be developed as a “smart all-in-one” type whose in-vivo safety and effectiveness is to be evaluated through performance in pivotal clinical studies as well as precli

< R&D Goal >
Final Goal:a multi-purpose cardiopulmonary circulatory assistive device that can be used for various indications is to be developed as a “smart all-in-one” type whose in-vivo safety and effectiveness is to be evaluated through performance in pivotal clinical studies as well as preclinical animal experiments.
The research goals for each sub-project to achieve the final research goal are as follows;
Sub-project1:To establish the Korean patient registry, to establish the animal model for various cardiopulmonary dysfunction, and to perform animal experiments and clinical trials of the developed smart all-in-one cardiopulmonary circulatory assist device.
Sub-project2:To integrate all components of a multi-use smart all-in-one cardiopulmonary circulation assist device, to design and manufacture the automatic control unit of the smart all-in-one cardiopulmonary circulation assist device, to perform bench-top performance tests, and finally to produce prototypes that can be tested in human trials.
Sub-project3:To design and develop of a centrifugal blood pump to be integrated into cardiopulmonary circulatory assistive device that can be used for various purposes such as emergency, intra-operative, post-operative intensive care and long-term cardiopulmonary assist
Sub-project4:To perform basic research and product development of a blood oxygenator for smart all-in-one cardiopulmonary circulation assist device

< Research Content >
From the prototyping of the “smart all-in-one” cardiopulmonary circulatory assistive device to the pivotal clinical trial of the newly developed level-4 medical device to confirm its safety and effectiveness, the following research contents were developed and performed by each sub-project team
Sub-project1:Establishing core technical requirements of cardiopulmonary circulatory assistive devices, conducting preclinical experiments by utilizing self-developed various cardiopulmonary dysfunction animal models, establishing domestic ECMO patient registry, and conducting pivotal clinical trial after obtaining permission from Korean FDA(Ministry of Food and Drug Safety)
Sub-project2:Development of sensor module, control algorithm, and drive console for cardiopulmonary circulatory assist device, system integration of the smart all-in-one type cardiopulmonary circulatory support system, in vitro performance evaluation of the developed system
Sub-project3:Design and manufacture of a centrifugal blood pump, prediction and optimization of blood pump performance and safety(hemolysis level) using a computational fluid dynamics analysis, heat exchanger design for oxygenator development
Sub-project4:Design of a blood oxygenator structure, development of manufacturing technology and surface modification method to improve blood compatibility

< Research Results >
- In 2019, we completed the “Smart All-in-One Cardiopulmonary Circulatory Support System” prototype and obtained the approval for pivotal clinical trials on the newly developed medical device from the Ministry of Food and Drug Safety, which was the first case for a level4 electronic medical equipment developed in Korea.
- The system was tried as an ECMO(ExtraCorporeal Membrane Oxygenation) to a patient who suffered from pulmonary failure and waiting for lung transplantation. ECMO is a medical device that supplies oxygen to the patient's blood through artificial lungs and circulates it into the body using a blood pump, which is essential for the treatment of severe cardiopulmonary insufficiency patients

- It has become an exemplary model of government-funded research and development project through successful product development and clinical application by researchers and also successful clinical trial with the guidance of governmental agencies of the Ministry of Health and Welfare/Koreans Health Industry Development Institute and the Ministry of Food and Drug Safety. It is expected to open the era of domestic production of high level medical devices.

(출처 : SUMMARY 5p)

목차 Contents

• 표지 ... 1
• 제출문 ... 2
• 보고서 요약서 ... 3
• 요약문 ... 4
• SUMMARY ... 5
• 6.1 총괄연구개발과제의 연구성과 실적 및 향후 계획 ... 7
• 6.2 연구성과 유형별 세부 내역 ... 9
• 7. 참여연구원 현황표 ... 24
• 목차 ... 25
• 1. 연구개발과제의 개요 ... 26
• 1-1. 연구개발 목적 ... 26
• 1-2. 연구개발의 필요성 ... 26
• 1-3. 연구개발 범위 ... 26
• 2. 국내외 기술개발 현황 ... 27
• 3. 연구수행 내용 및 결과 ... 31
• 4. 목표달성도 및 관련분야 기여도 ... 179
• 4-1. 목표달성도 ... 179
• 4-2. 관련분야 기여도 ... 182
• 5. 연구결과의 활용계획 ... 187
• 6. 연구과정에서 수집한 해외과학기술정보 ... 188
• 7. 연구개발성과의 보안등급 ... 188
• 8. 국가과학기술종합정보시스템에 등록한 연구시설·장비 현황 ... 189
• 9. 연구개발과제 수행에 따른 연구실 등의 안전조치 이행실적 ... 189
• 10. 연구개발과제의 대표적 연구실적 ... 190
• 11. 기타사항 ... 197
• 12. 참고문헌 ... 197
• 별첨4. 실적 증빙자료 ... 200
• 끝페이지 ... 323