Annual Report 2023
Division of Surgical Technology
Masaaki Ito, Takahiro Kinoshita, Nobuyoshi Takeshita, Yasuyuki Yoshida, Kimimasa Sasaki
Introduction
The main purpose of the Division of Surgical Technology is to develop surgical devices that are truly necessary, to deliver them to the clinical fields, and to prove their safety and efficacy through clinical trials.
The Team and What We Do
By cooperation with the Center of New Surgical and Endoscopic Development for Exploratory Technology (NEXT), we have started to promote surgical device development consisting of clinical need selection, prototype design, POC (Proof of Concept) establishment, validation, and clinical trials. In addition, we will create an innovative medical development roadmap by establishing a hub for surgical device development in the National Cancer Center Hospital East (NCCHE) and building up a clinical supportive team for early-phase surgical device development.
Research Activities
Cooperation with the NEXT
We have strengthened the system for surgical device development with the support of coordinators for surgical innovation, intellectual property experts and regulatory experts in cooperation with the NEXT. While focusing on the development of medical devices through joint research and development with academia, we have advanced the development of medical devices and the establishment of a clinical trial implementation system in collaboration with the NEXT.
Innovative surgical robotic system developed by NCC-certified venture company, Asahi Surgical Robotics
We are developing an innovative robotic surgical instrument in collaboration with Asahi Surgical Robotics Co., Ltd. (Formerly A-Traction Inc., established in August 2015, acquired by Asahi Intecc Co., Ltd. in July 2021), an NCC-certified venture company. This device is a robot that supports laparoscopic surgery like an assistant beside the surgeon. Non-clinical trials to obtain approval to manufacture and sell the product were conducted in 2022, and it received regulatory approval from the PMDA in February 2023. It was introduced clinically in November 2023.
Platform development for the system for clinical trial operations
As a specific clinical study on the surgical application of oxygen saturation imaging developed at our hospital, we have carried out a "pilot study on intestinal blood flow evaluation using oxygen saturation imaging", and we indicated the effectiveness of the method. We are planning specified clinical trial aimed at obtaining insurance reimbursement.
Activities to match needs and seeds
To create opportunities for medical device development by companies in Chiba Prefecture and Tokyo, we have organized the event "Medical Needs and Engineering Seeds Matching Meeting in Oncology Field" with the National Cancer Center Hospital (NCCH) and Cancer Institute Hospital in Japanese Foundation for Cancer Research (JFCR) in cooperation with Chiba Prefecture, Tokyo and Tokyo Medical-Engineering collaboration HUB.
Development of medical devices using new biodegradable polymers
Joint research on spacers used in radiofrequency ablation, cryosurgery, and radiation therapy was initiated with the Departments of Diagnostic Radiology, Urology, and Radiation Therapy at the Hospital East, and the Departments of Diagnostic Radiology and Radiation Therapy at the Hospital. The research was funded by the 2023 “Support Program for Young Researchers to Solve Start-up Problems”. In addition, a venture company (Medseed Co., Ltd.) was established using the results of this research.
Research and development of deep learning models and automated skill evaluation systems in hepatobiliary and pancreatic surgery
In collaboration with the hepato-biliary-pancreatic surgery department in the Hospital East, we have developed deep learning models which automatically recognize bleeding or vessels in liver transection plane using operative videos of laparoscopic hepatectomy. We have also started research and development of the automated skill evaluation system in laparoscopic hepatectomy, applying the models we have developed so far.
Clinical Trials
We conducted a pilot study as part of the research on intestinal blood flow evaluation using oxygen saturation imaging.
Education
We held regular in-house seminars to teach surgical device innovation for the development of human resources.
Future Prospects
We aim to establish a clinical support team for early-phase surgical device innovation and to develop a roadmap for surgical device innovation.
List of papers published in 2023
Journal
1. Ryu K, Kitaguchi D, Nakajima K, Ishikawa Y, Harai Y, Yamada A, Lee Y, Hayashi K, Kosugi N, Hasegawa H, Takeshita N, Kinugasa Y, Ito M. Deep learning-based vessel automatic recognition for laparoscopic right hemicolectomy. Surgical endoscopy, 38:171-178, 2024
2. Sasaki S, Kitaguchi D, Takenaka S, Nakajima K, Sasaki K, Ogane T, Takeshita N, Gotohda N, Ito M. Machine learning-based Automatic Evaluation of Tissue Handling Skills in Laparoscopic Colorectal Surgery: A Retrospective Experimental Study. Annals of surgery, 278:e250-e255, 2023
3. Hasegawa H, Takeshita N, Hyon W, Hyon SH, Ito M. Novel external reinforcement device for gastrointestinal anastomosis in an experimental study. BMC surgery, 23:121, 2023
4. Igaki T, Kitaguchi D, Matsuzaki H, Nakajima K, Kojima S, Hasegawa H, Takeshita N, Kinugasa Y, Ito M. Automatic Surgical Skill Assessment System Based on Concordance of Standardized Surgical Field Development Using Artificial Intelligence. JAMA surgery, 158:e231131, 2023
5. Kitaguchi D, Harai Y, Kosugi N, Hayashi K, Kojima S, Ishikawa Y, Yamada A, Hasegawa H, Takeshita N, Ito M. Artificial intelligence for the recognition of key anatomical structures in laparoscopic colorectal surgery. The British journal of surgery, 110:1355-1358, 2023