development status

Development of an Ultra-fine Endoscope
(Medical Device)

An important aspect of medical device development is the emphasis on the needs and ideas in the medical field. Even if the seed’s technology is excellent, if there is no need in the medical field or it is inappropriate for the specifications in the medical field, medical application is difficult. Therefore, by examining the perspective of commercialization from the early stages of development, we first developed solutions from the medical needs in the medical field and performed optimization development with the image of the final medical device (product) in the medical field. By referring to a technology called “Bio-design” that had been developed at Stanford University in the United States as a human resource development program for innovative and most optimized medical device development, the Bio-design program was started in 2015 at Tohoku University, the University of Tokyo, and Osaka University.

While incorporating the Bio-design techniques, we develop medical devices by utilizing the perspective of focusing on understanding medical needs in the medical field and by utilizing the accumulated experiences and know-hows from numerous investigator-driven clinical trials with networks among many physicians and clinical departments.

As a first example, a disposable ultrafine endoscope is illustrated below.

■ Can the abdominal cavity be observed non-invasively? (medical issues and needs).

Peritoneal dialysis is a treatment that is relatively stress-free for patients and can be medically economical because it allows purification of body waste at home without going to a dialysis facility. Although it is convenient, the peritoneum deteriorates over time. If the peritoneum deterioration is detected too late, serious life-threatening complications such as peritoneal sclerosis may develop. In those cases, peritoneal dialysis is often interrupted after about 5 years. The only way to check the condition of the peritoneum is by open surgery or rigid mirror observation. There is a growing need in medical practice to monitor the peritoneal condition more easily and without burden on the patient.

■ Medical device under development (treatment ideas and concepts)

Patients undergoing peritoneal dialysis are inserted a tube into the peritoneum to inject dialysate. We conceived an idea and the concept of noninvasively observing the abdominal cavity if we had an endoscope that could be inserted through this thin tube.

Based on the opinions of physicians, we collaborated with companies that have fiberscope technology and developed an ultra-fine endoscope with a diameter of about 1 mm that is suitable for the specifications at the medical sites. The tip of the endoscope has been made disposable with a focus on hygiene. We developed it with the concept that it does not impose a burden on medical economics and is easy to handle.

We have conducted joint research with physicians and medical professionals at Tohoku University, Juntendo University, Jikei University School of Medicine, The University of Tokyo, Tokai University, Fukushima Medical University, etc. and subsequently, we conducted an investigator-initiated clinical trial at Juntendo University and Jikei University School of Medicine. In May 2020, we have signed an license agreement with a global medical device company that is preparing for regulatory approval and commercialization of this endoscope.

This medical device has been developed with a different concept from conventional endoscopes for gastroenteric observations. It can be inserted through a gastrostomy tube, urethral balloon, tracheal tube, injection needle, etc. so that various clinical usefulness can be expected.