초록 ▼

본 연구는 실시간 초음파 영상을 이용한 자궁근종 대상 질 삽입식 정밀 근접 치료용 신개념 초음파 융합 치료기 개발을 통한 신시장 창출 기반 마련하는 것을 목적으로 함.
○ 질 삽입식 초음파 융합 치료기 디자인 개발 및 목업 제작, 융합 치료기 각 모듈에 대한 시제품 제작
○ 고해상도 영상 기법 및 실시간 가이드 영상 기법 개발
○ 개발 프로브에 대한 팬텀 이미지 평가 완료
○ 자궁근종 코호트 구축 완료(108명)
○ 치료헤드 목업에 대한 환자 불편감 평가 완료
○ 동물실험 프로토콜 완료
○ 국내

본 연구는 실시간 초음파 영상을 이용한 자궁근종 대상 질 삽입식 정밀 근접 치료용 신개념 초음파 융합 치료기 개발을 통한 신시장 창출 기반 마련하는 것을 목적으로 함.
○ 질 삽입식 초음파 융합 치료기 디자인 개발 및 목업 제작, 융합 치료기 각 모듈에 대한 시제품 제작
○ 고해상도 영상 기법 및 실시간 가이드 영상 기법 개발
○ 개발 프로브에 대한 팬텀 이미지 평가 완료
○ 자궁근종 코호트 구축 완료(108명)
○ 치료헤드 목업에 대한 환자 불편감 평가 완료
○ 동물실험 프로토콜 완료
○ 국내 논문 1편 게재, 국제 SCI급 논문 1편 제출, 국제학회 3편 게재확정
○ 국내 특허 출원 4건, 국외 특허 출원 2건
○ 산부인과에 익숙한 질 삽입을 통한 자궁근종 HIFU 치료는 자궁내막을 보호할 수 있고, 척추 통증 없이 정밀치료가 가능하기 때문에 중소병원에까지 시장을 확장할 수 있을것으로 기대됨

(출처 : 보고서 요약서 3P)

Abstract ▼

Purpose & Contents
Development of an Ultrasound Fusion Therapy System Using Real-time Ultrasound Images for Non-Invasive, Precise and Close Treatment of Uterine Fibroids.
◦ Design and production of transvaginal type treatment head
- An transvaginal type transducer integrated to diagnose and

Purpose & Contents
Development of an Ultrasound Fusion Therapy System Using Real-time Ultrasound Images for Non-Invasive, Precise and Close Treatment of Uterine Fibroids.
◦ Design and production of transvaginal type treatment head
- An transvaginal type transducer integrated to diagnose and treat simultaneously
- 3 dimensional navigation system of the treatment head for high efficient volumetric treatment
◦ Minimization of the fusion system for maximizing an efficiency and an economic merit by integration of a diagnosis module and a treatment
- Integration of a diagnosis module and a treatment module into a fusion system in size of a general ultrasound diagnosis device
- Diagnosis module platform for the development of HIFU treatment monitoring method based on shear wave elasticity
◦ Development of pre-clinical and clinical protocols
- Development of animal test model and report
◦ In this project, high-precision real-time focused ultrasound (FUS) monitoring techniques were developed for accuracy, efficiency, and safety of planning, guiding, and evaluating non-invasive focused ultrasound treatment.
◦ Specifically, it is to overcome limitations of current ultrasound monitoring techniques from the conventional extracorporeal uterine fibroid therapy system taking advantage of a new conceptual precise and close ultrasound therapy system and original technology of ultrasound imaging that had been acquired.
◦ The purpose is to make the world-first, vaginal, high intensity focused ultrasound (HIFU) therapy device for uterine leiomyoma via clinical data collection of women with leiomyoma, image quality evaluation of ultrasound component of device, hearing of experts' and consumers' opinion, optimization of size of vaginal probe.

Results
◦ Transvaginal type treatment head
- Design/production completion of micro convex image transducer
- Design/production completion of micros phased array HIFU transducer
- Design/production completion of wobbling mechanism for volumetric treatment
◦ Fusion system by integration of a diagnosis and a treatment
- Industrial design completion of fusion system
- Development completion of RF base diagnosis module for HIFU treatment
◦ Design/Manufacturing completion of the positioning arm
◦ Completion of GUI and Touch Panel Design
◦ Development completion of pre-clinical and clinical protocols
◦ High-speed/high-resolution imaging technique was developed for high-precision monitoring and it shows 1.8 times better resolution and 2 times higher SNR compared with the conventional technique. (1st phase goal: 1.5 times for resolution, 2 times for SNR)
◦ HIFU signal interference reduction technique for ultrasound therapy monitoring was also developed and it can provide ultrasound image at a rate of more than 36 frame/sec even during the HIFU transmission. (1st phase goal: 20 frame/sec)
◦ Techniques for detecting cavitation caused by HIFU transmission was developed and it shows accuracy of more than 78%. (1st phase goal: 70%)
◦ Shear wave elastography for evaluating the thermal lesion of FUS treatment using a transvaginal transducer was suggested and it presents accuracy of about 85%. (1st phase goal: 70%)
◦ Quantitative achievements
◦ Clinical data collection of women with leiomyoma: The average size of leiomyoma was 4.1cm * 3.3cm. The average distance bwtween leiomyoma and vaginal probe was 3.2cm. Many women prefer HIFU to surgery for treatment of leiomyoma.
◦ Image quality evaluation of ultrasound component of device: When the ultrasound device with the limited range of image acquisition was used, it is difficult to locate leiomyoma within the range of image acquisition. However, locating leiomyoma within the range of image acquisition and identifying leiomyoma were possible in all cases, ultimately. Based on phantom examination, the image quality of ultrasound of HIFU therapy device was comparable to that of diagnostic ultrasound device.
◦ Hearing of experts' and consumers' opinion: According to experts and consumers opinions, the diameter of vaginal probe should be around 3cm; the therapy time should be within 30min; the price of device should be within \500,000,000. They thought vaginal HIFU had some advantages over abdominal HIFU. However, dissolution of technology barrier, proof of efficacy and safety should be addressed.
◦ Optimization of size of vaginal probe: Vaginal insertion of probe were possible in all women and most women reported mild discomforts. However, few women complained moderate pain during vaginal probe insertion. During maintenance, pain seemed to decrease.

Expected Contribution
◦ The HIFU system to be developed in this study enable to create the new market of 90 billion won for treatment of ulterine fibroides. And since the system can be applicable to treatment of adenomyosis and uterine polyp, additional new market creation will be possible. The minimization technology of the HIFU system can be applied to prostate cancer and breast cancer, so it is possible to create the alternate market for the treatment devices for prostate cancer, which all are now imported.
◦ The developed high-speed/high-resolution imaging technique can be utilized for endoscopic ultrasound diagnosis and theragnosis based on photoacoustic imaging as well as the FUS monitoring.
◦ The lesion detection technique using shear wave elastography is considered an innovative achievement in a sense that it can provide the evaluation of the treatment by characterizing the targeted tissue which is more reliable than the conventional monitoring techniques of ultrasound-guided FUS (USgFUS). The research is expected to create a new market by making it possible to diagnosis in early stage and predict prognosis of treatment.
◦ Through this project, the performance of USgFUS including guide image, real-time monitoring, treatment evaluation will be enhanced and the workflow will be also improved reducing treatment time. In addition, since the USgFUS requires relatively low cost, this research can yield market expansion toward small- and medium-sized hospitals.
◦ Via clinical data collection of women with leiomyoma, image quality evaluation of ultrasound component of device, hearing of experts' and consumers' opinion, optimization of size of vaginal probe, we can optimize the device. Specfically, we can decide the power and focus distance of HIFU, the image quality of ultrasound component of the device, acceptable price range of device, the diameter of vaginal probe. Using these information, we will construct world-first, vaginal, HIFU therapy device and prove its efficacy and safety through preclinical and clinical studies.

(출처 : SUMMARY 7P)

목차 Contents

• 표지 ... 1
• 제 출 문 ... 2
• 보고서 요약서 ... 3
• SUMMARY ... 7
• Contents ... 10
• 목차 ... 11
• 제1장. 연구개발과제의 개요 ... 12
• 제2장. 국내외 기술 개발 현황 ... 20
• 제3장. 연구 수행 내용 및 성과 ... 22
• 1세부 : 알피니언메디칼시스템(주) ... 22
• 2세부 : 서강대학교 산학협력단 ... 46
• 3세부 : 분당서울대학교병원 ... 76
• 제4장. 연구개발성과의 활용 계획 ... 88
• 제5장. 연구 과정에서 수집한 해외 과학기술 정보 ... 91
• 제6장. 연구개발성과의 보안등급 ... 94
• 제7장. 국가과학기술종합정보시스템에 등록한 연구시설·장비 현황 ... 95
• 제8장. 연구개발과제 수행에 따른 연구실 등의 안전 조치 이행 실적 ... 96
• 제9장. 연구개발과제의 대표적 연구 실적 ... 99
• 제10장. 기타 사항 ... 100
• 제11장. 참고 문헌 ... 101
• 끝페이지 ... 103