Development of innovative techniques for the endoscopic implantation and securing of a novel, wireless, miniature gastrostimulator (with videos)

Abstract

Background Gastric stimulation via high-frequency, low-energy pulses can provide an effective treatment for gastric dysmotility; however, the current commercially available device requires surgical implantation for long-term stimulation and is powered by a nonrechargeable battery. Objective To test and describe endoscopic implantation techniques and testing of stimulation of a novel, wireless, batteryless, gastric electrical stimulation (GES) device. Design Endoscopic gastric implantation techniques were implemented, and in vivo gastric signals were recorded and measured in a non-survival swine model (n = 2; 50-kg animals). Intervention Five novel endoscopic gastric implantation techniques and stimulation of a novel, wireless, batteryless, GES device were tested on a non-survival swine model. Main Outcome Measurements Feasibility of 5 new endoscopic gastric implantation techniques of the novel, miniature, batteryless, wireless GES device while recording and measurement of in vivo gastric signals. Results All 5 of the novel endoscopic techniques permitted insertion and securing of the miniaturized gastrostimulator. By the help of these methods and miniaturization of the gastrostimulator, successful GES could be provided without any surgery. The metallic clip attachment was restricted to the mucosal surface, whereas the prototype tacks, prototype spring coils, percutaneous endoscopic gastrostomy wires/T-tag fasteners, and submucosal pocket endoscopic implantation methods attach the stimulator near transmurally or transmurally to the stomach. They allow more secure device attachment with optimal stimulation depth. Limitations Non-survival pig studies. Conclusion These 5 techniques have the potential to augment the utility of GES as a treatment alternative, to provide an important prototype for other dysmotility treatment paradigms, and to yield insights for new technological interfaces between non-invasiveness and surgery.

Novel Diet, Drugs, and Gastric Interventions for Gastroparesis

“…Deb et al 85 developed a novel, wirelessly powered miniature gastric electrical stimulation device implanted into the pig stomach through an over-tube and attached to the gastric mucosa with endoclips. 86 Electrogastrogram recordings have demonstrated more consistent gastric slow wave amplitudes compared to with no stimulation.…”

Development of an Autonomous Endoscopically Implantable Submucosal Microdevice Capable of Neurostimulation in the Gastrointestinal Tract

“…Currently, submucosal techniques represent a new challenge for therapeutic endoscopists. Considering our past experiences with these techniques, we decided to implant the stimulation device directly into the submucosa, using the endoscopic submucosal pocket technique [ 14 ]. This particular method is proven to be relatively safe, simple, and minimally invasive.…”

“…The endoscope was then extracted, equipped with a dissection cap (15.5 mm FujiFilm lens Hood), and then inserted into the stomach again. In order to implant the device into the submucosal layer in the pyloric antrum, a technique first described by Deb et al, called an endoscopic submucosal pocket (ESP), was used [ 14 ]. Following the application of a saline solution combined with methylene blue into the submucosal layer using an injection therapy needle catheter (Boston Scientific, 25G), a horizontal incision was made in order to create an opening in the submucosa using a Dual Knife (Olympus; electrosurgical knife with knob-shaped tip).…”

Slow wave conduction patterns in the stomach: from Waller's Foundations to Current Challenges

“…The ability to integrate recording and stimulation/pacing technologies into endoscopically implantable device is a fertile area of research in the near future (Deb et al . , Farajidavar et al . ).…”

“…Further studies are necessary to determine the mechanisms underlying such devices. The ability to integrate recording and stimulation/pacing technologies into endoscopically implantable device is a fertile area of research in the near future (Deb et al 2012, Farajidavar et al 2012.…”