Developing the world's first metal stent for biliary tract to suppress food reflux
Oct 08, 2024
Professor Kwon Chang-il's team at Bundang Cha Hospital (Director Yoon Sang-wook) of Cha Medical University developed the world's first stent for biliary tract in which a part of the stent is bent freely in a joint study with a research team of senior researcher Moon Jong-pil of MI Tech (CEO Kwak Jae-oh).
The stent for the bent biliary tract has been approved by the Ministry of Food and Drug Safety for product approval and can be used in clinical practice. This stent is a stent with anti-reflux function for patients with food reflux, and additional studies will be conducted at seven university hospitals in Korea, including Bundang Cha Hospital, to verify the duration of anti-reflux function.
The biliary tract is a digestive organ that flows bile (bile) produced by the liver to the duodenum, and when blocked by gallstones, cancer, or tumors, a stent for the biliary tract is inserted to help digest food by allowing bile to flow normally toward the duodenum.
Conventional digestive system metal stents were all straightened to expand the occluded area. However, when applied to patients lying down due to poor general condition, food in the duodenum was more likely to flow back into the biliary tract. When food flows backward, biliary tract inflammation occurs frequently, and biliary tract stones are mixed with flowing bile to form biliary stones, which can cause stent obstruction early.
Research has been actively conducted for 15 years to develop a metal stent for the biliary tract that complements the problem of food reflux in the duodenum, but there has been no significant progress as results have been reported that stent dysfunction may occur early due to the functional problem of the anti-reflux valve.
The research team conducted a basic experiment and reported that the antireflux valve was damaged by gastric acid mixed with food introduced into the duodenum (BMC Gastroenterology, 2018). Accordingly, instead of attaching a valve to an existing stent, it was designed and manufactured to prevent food from flowing back by completely adjusting the direction of bile drainage toward the lower part of the duodenum. As a result of the five-year study, the Ministry of Food and Drug Safety approved the final sale after successfully proving and supplementing the antirefuge function through basic animal experiments.
Professor Kwon Chang-il of the Department of Gastroenterology at Bundang Cha Hospital said, "The new stent will be able to maximize the effect of customized treatment and prevent complications for patients with biliary obstruction and problems with stent function due to continued reflux of duodenal food," adding, "Since November this year, additional studies to see how long the antireflux function is maintained for patients with frequent reflux of food will be conducted at 7 university hospitals in Korea (Yeonui University Gangnam Severance Hospital, Ulsan University Seoul Asan Hospital, Busan University, Inha University Hospital, Inha University Hospital, Soon Chun Hyang University Cheonan.
"With this product development and approval from the Ministry of Food and Drug Safety, we will expand the scope of research and development of metal stents focused on patient-specific treatment and will be available to patients at major university hospitals nationwide," said Kwak Jae-oh, CEO of MI Tech Co., Ltd. "We plan to supply it to the world through a global network."
The stent for the bent biliary tract has been approved by the Ministry of Food and Drug Safety for product approval and can be used in clinical practice. This stent is a stent with anti-reflux function for patients with food reflux, and additional studies will be conducted at seven university hospitals in Korea, including Bundang Cha Hospital, to verify the duration of anti-reflux function.
The biliary tract is a digestive organ that flows bile (bile) produced by the liver to the duodenum, and when blocked by gallstones, cancer, or tumors, a stent for the biliary tract is inserted to help digest food by allowing bile to flow normally toward the duodenum.
Conventional digestive system metal stents were all straightened to expand the occluded area. However, when applied to patients lying down due to poor general condition, food in the duodenum was more likely to flow back into the biliary tract. When food flows backward, biliary tract inflammation occurs frequently, and biliary tract stones are mixed with flowing bile to form biliary stones, which can cause stent obstruction early.
Research has been actively conducted for 15 years to develop a metal stent for the biliary tract that complements the problem of food reflux in the duodenum, but there has been no significant progress as results have been reported that stent dysfunction may occur early due to the functional problem of the anti-reflux valve.
The research team conducted a basic experiment and reported that the antireflux valve was damaged by gastric acid mixed with food introduced into the duodenum (BMC Gastroenterology, 2018). Accordingly, instead of attaching a valve to an existing stent, it was designed and manufactured to prevent food from flowing back by completely adjusting the direction of bile drainage toward the lower part of the duodenum. As a result of the five-year study, the Ministry of Food and Drug Safety approved the final sale after successfully proving and supplementing the antirefuge function through basic animal experiments.
Professor Kwon Chang-il of the Department of Gastroenterology at Bundang Cha Hospital said, "The new stent will be able to maximize the effect of customized treatment and prevent complications for patients with biliary obstruction and problems with stent function due to continued reflux of duodenal food," adding, "Since November this year, additional studies to see how long the antireflux function is maintained for patients with frequent reflux of food will be conducted at 7 university hospitals in Korea (Yeonui University Gangnam Severance Hospital, Ulsan University Seoul Asan Hospital, Busan University, Inha University Hospital, Inha University Hospital, Soon Chun Hyang University Cheonan.
"With this product development and approval from the Ministry of Food and Drug Safety, we will expand the scope of research and development of metal stents focused on patient-specific treatment and will be available to patients at major university hospitals nationwide," said Kwak Jae-oh, CEO of MI Tech Co., Ltd. "We plan to supply it to the world through a global network."
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