Development of Disposable Ultrafine Endoscopes
(Medical Device)



There are many cases in which excellent technologies are difficult to apply (put to practical use) in medicine because they do not meet the issues and needs of the medical field or is inappropriate for the specifications of the medical field, and many companies that possess the technologies face this problem. Our laboratory tries to develop medical devices and software as a medical device (SaMD) based on the idea of "Bio design", which is to propose solutions to problems starting from the needs of the medical field, optimize the development based on the image of the final product in the medical field, and achieve medical innovation. The disposable ultrafine endoscope is the medical device developed based on Bio design.

Peritoneal dialysis is a treatment method that enables home dialysis and has medical economic advantages. However, it is forced to be discontinued after about five years because the peritoneal membrane deteriorates over time and can cause serious complications. Currently, the only methods to check the condition of the peritoneum are laparotomy or laparoscopic observation, both of which are very burdensome for the patient. Patients on peritoneal dialysis have a tube inserted into the peritoneum to inject dialysate solution. Our laboratory has developed, in collaboration with several universities, an ultrafine endoscope that is inserted through this thin tube to noninvasively observe the intraperitoneal cavity. Based on the opinions of many physicians, this disposable product has an outer diameter of approximately 1 mm, which is suitable for specifications in the medical field. Juntendo University and The Jikei University School of Medicine conducted a validation study (investigator-initiated clinical trial) for regulatory approval.

This medical device was developed based on a different concept from conventional gastrointestinal endoscopes, and can be inserted through a gastrostomy tube, urethral balloon, tracheal tube, or injection needle, and is expected to have various clinical uses. It was approved by the Ministry of Health, Labor and Welfare in December 2022.

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