GI Leak Drainage Device
Deployment of a leakage-reducing device at a leaking site – A non-surgical, non-laparoscopic approach for the device is delivered endoscopically to the leaking site
Anastomotic leakage (AL) is one of the most feared complications during gastrointestinal surgery. It causes considerable morbidity and mortality and contributes to local tumor recurrence. Quality of life is often affected for long periods of time, due to long hospitalizations and poor functional outcomes with high rates of temporary or even permanent stoma formation.
There is a great need for an endoscopic device that can be easily deployed and managed with a high rate of success in enhancing healing of the leakage site and hence reducing the need for surgery.
Inventors
Dr. Doron Kopelman, Emek Medical Center
Contact info
Avital Pritz, Director of Medical Devices and Digital Health
For further information please contact:
avital@mor-research.comOur solution suggests an endoscopic approach, e.g. a non-surgical and non-laparoscopic approach for the deployment of a leakage reducing device at a leaking site. The device is delivered endoscopically to the leaking site.
The device is composed of two opposing inflatable rings that are deployed via the leaking defect at the anastomosed tissue walls and then inflated to occlude the opening through which leakage was detected.
The rings are mounted on a draining tube positioned to extend from the leaking site to outside of the body via the mouth or the anus or alternatively remain within the lumen of the GI tract distal to the leaking site.The same principle can allow also the placement of the device from the opposite direction (e.g. laparoscopically via the trocar, through the skin of the abdominal or thoracic wall) to occlude further leakage and help in achieving surgical control of the leaking site. Once leaked content is drained over a few days, and the leaking site has healed naturally, the balloons are deflated, and both balloons and tube can be pulled out.
The rings are mounted on a draining tube that is positioned to extend from the leaking site to outside of the body via the mouth or the anus or alternatively remain within the lumen of the GI tract distal to the leaking site.The same principle can allow also the placement of the device from the opposite direction (e.g. laparoscopically via the trocar, through the skin of the abdominal or thoracic wall) to occlude further leakage and help in achieving surgical control of the leaking site. Once leaked content is drained during a few days, and the leaking site is healed by natural healing process the balloons are deflated and both balloons and tube can be pulled out.
The global anastomosis devices market in terms of revenue was estimated to be worth $3.0 billion in 2022 and is poised to reach $4.4 billion by 2027, growing at a CAGR of 8.3% from 2022 to 2027. A subsequent growth in the number of surgical procedures and the growing demand for MI surgeries and tech advancements, are major drivers of growth in this market.
The incidence of Anastomosis Leakage ranges from 1% to 30% with the risk varying depending on the site of the anastomosis: relatively higher rates of leakage are typical of esophageal anastomosis, gastric leaks post bariatric surgery and rectal anastomoses with those placed < 5 cm from the anal verge being particularly vulnerable.
Inpatient costs are reported to be 108% higher for patients with AL versus no AL, with key cost contributors to be ward stay, disposables, operating room, hospital consultations, extended length of stay and increased odds of reoperation, and ICU stay.
Concept developed