Technologies

GI Anastomosis Leak Detector

  • Category: Medical Devices
  • Investment Status: Pre-Seed
  • Medical Field: Gastroenterology
  • Patent Status: PCT
  • Development Status: In POC development
  • Medical Center: Beilinson
  • Inventors: Dr. Matan Ben David

Gastrointestinal leaks are perhaps the most dreaded complication after abdominal surgery. They can occur after the creation of an anastomosis for the continuity of the GI tract, or from remodeling of organs such as the stomach in bariatric or esophageal surgery. Some leaks present in a dramatic fashion early in the postoperative period, leaving little doubt about the diagnosis. However, many others present in a far more subtle fashion, often relatively late in the postoperative period and often after initial hospital discharge, and can be difficult to distinguish from other postoperative infectious complications. The symptoms of a leak are so non-specific that it is extremely difficult for a doctor to decide whether deterioration in the condition of a patient after surgery is due to general weakness after the operation, infection, or a leak. There is then a delay of several days until a decision is made to send the patient for a CT scan, which presents a high false negative rate, to determine whether there is indeed a leak, and even longer to send the patient for further surgery to correct it. Anastomotic leaks are inevitable complications affecting between 2% and 30% of patients undergoing gastrointestinal surgery. They result in serious disease including death in between 1 in 3 and 1 in 4 patients. There is general agreement that early diagnosis of an anastomotic leak is crucial for the prevention of death. There is a desperate need for a device that will determine unequivocally, as soon as deterioration of the patient’s condition is noted, whether or not leakage is the cause. The device needs to be sufficiently low-cost as to make it appropriate for general use.

Technology: The device consists of a biodegradable polymer-based mesh that is placed around the staple lines. This is connected by wires passed through the skin to an external unit which detects leakage by measuring electrical impedance in the wires over time. The physician has the choice of whether or not and when to start the monitoring process.

Does not involve imaging
Low cost
Sensitive and specific
Enables continuous monitoring for early detection when and if the physician chooses
Precludes exploratory surgery to detect leaks