Acute pancreatitis is the third most common gastrointestinal disorder requiring hospitalization. Severe necrotizing pancreatitis is a life-threatening complication developed in approximately 20% of patients. Its mortality rate range from 15% in patients with sterile necrosis up to 30% in case of infected one associated with multi-organ failure. Minimally invasive or endoscopic transluminal drainage and necrosectomy are the standard of care for infected pancreatic fluid collections and necroses after pancreatitis. In an endoscopic treatment algorithm, necroses beyond the reach of safe endoscopic access are typically treated by percutaneous drainage. Minimally invasive approaches for infected pancreatic necrosis has increased over time while open necrosectomy has declined, because open approaches compared to drainage only or minimally invasive debridement were associated with greater odds of numerous in-hospital complications and resource burden. There is a large variety of necrosectomy techniques: blind entry using electrosurgical incision into a visible bulge in the stomach or duodenum, endoscopic ultrasound (EUS) guided access, electrocautery for hot access under EUS-guidance, cold access applying balloon dilation over a wire, use or no use of lavage solutions, and some studies have reported initial drainage followed by debridement days to weeks after the initial procedure versus debridement at the index procedure. However, there is still no drainage system on the market having a sufficient diameter for comfortable removal of the often bulky necrotic tissue in acute pancreatitis.
The dilation system enables the dilation of narrow channels that arise after the placement of thin drains using a puncture needle into a pathological focus in the target organ or cavity. The placement is carried out under ultrasound or X-ray control. The newly developed drainage system is designed for subsequent dilation of the channel through which a thin drain is introduced. A set of dilators is used for dilation, and the method of dilation is based on unique approach: a dilator with a larger diameter is inserted into a dilator with a smaller diameter. In this way, it is possible to gradually and gently dilate the channel without damaging the surrounding tissues. The depth of the introduced dilator is determined by a fixation device (dilation ring), which can be used to safely set the depth of the dilated channel. The system could help to standardize the dilation procedure to access the necrosis.
We intend to use the dilation system for drainage in patients with infectious and necrotic collections in the abdominal cavity, retroperitoneum, chest cavity, but also for dilation of access routes to hollow organs (trachea, stomach, uterus, urinary system). It can also be used during laparoscopic procedures. The use of the our device will enable safer dilation of access routes for effective introduction of drains and will help to performendoscopic procedures and instrumental procedures in body cavities and necrotic collections.
Technology is owned by University Hospital Hradec Králové. Czech patent application filed (priority date 7. 12. 2022). 3D printed set of dilators were tested in vivo in pig model, where all the expected benefits were confirmed by the clinician. The development was supported by the Technology Agency of the Czech Republic within the programme for applied research, experimental development and Innovation GAMA 2 – Project TP01010034 – Centre for Transfer of Biomedical Technologies – PoC2.
Team of Inventors
prof. Luboš Sobotka, CSc.
University Hospital Hradec Králové
The 3rd Department of Internal Medicine - Metabolic Care and Gerontology
Principal investigator & coinvestigator of multiple research projects and clinical studies
Member of the European Society for Clinical Nutrition and Metabolism, the Czech Society for Clinical Nutrition and Intensive Metabolic Care
Owner of multiple patents & licensed technology
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