Wirelessly Powered Endoscopically Implantable Devices into the Submucosa as the Possible Treatment of Gastroesophageal Reflux Disease

Abstract

Gastroesophageal reflux disease (GERD) is a rather common disease with a prevalence reaching up to 10 or 20% in the western world. The most specific symptoms which point to the diagnosis of GERD are feelings of heartburn and the regurgitation of acidic stomach contents into the esophagus. However, a certain number of patients do not respond to standard therapy, and in these cases, it is necessary to resort to other treatment methods, such as laparoscopic fundoplication or electrostimulation of the lower esophageal sphincter. The aim of our work was to design and manufacture a miniature, battery-less stimulator to provide electric stimulation of the lower esophageal sphincter, which could be implanted deep into the submucosa of the distal esophagus. The main goal was to provide a battery-less system as opposed to traditional battery neurostimulators to reduce the size and weight of the device. An electronic prototype of a wirelessly powered implantable device was developed. We used animal models for the experiments. The device is designed to treat GERD via electrical stimulation of the muscularis propria. It is implanted into the submucosal pocket by the lower esophageal sphincter with an endoscope. This method of implantation is superior to esophageal stimulators used today because of very low invasiveness of the surgery. Bipolar neurostimulation via two gold-plated leads is provided. The device does not have any source of energy; it is powered wirelessly which reduces the risk of potential battery leakage and reduces the overall dimensions.