A Wireless Implantable System for Facilitating Gastrointestinal Motility

Abstract

Gastrointestinal (GI) electrical stimulation has been shown in several studies to be a potential treatment option for GI motility disorders. Despite the promising preliminary research progress, however, its clinical applicability and usability are still unknown and limited due to the lack of a miniaturized versatile implantable stimulator supporting the investigation of effective stimulation patterns for facilitating GI dysmotility. In this paper, we present a wireless implantable GI modulation system to fill this technology gap. The system consists of a wireless extraluminal gastrointestinal modulation device (EGMD) performing GI electrical stimulation, and a rendezvous device (RD) and a custom-made graphical user interface (GUI) outside the body to wirelessly power and configure the EGMD to provide the desired stimuli for modulating GI smooth muscle activities. The system prototype was validated in bench-top and in vivo tests. The GI modulation system demonstrated its potential for facilitating intestinal transit in the preliminary in vivo chronic study using porcine models.

High-Energy Pacing in the Jejunum Elicits Pulsatile Segmental Contractions

“…Similar findings were reported from a series of chronic high frequency stimulation studies conducted on the proximal jejunum where localized intestinal contractions were induced in response to each stimulus [42]. Based on histological analysis reported in that study, electrical stimulation did not damage the stimulation site while suturing the electrodes caused mild inflammation and hemorrhage, which were not clinically significant [42]. Future studies can enhance the evaluation of tissue integrity by extending the analysis to longer pacing durations and examining tissue inflammation using histological indices like the Geboes score and peripheral blood biomarkers, as well as measuring cellular stress through assessing damage to biomolecules such as DNA and RNA [43], [44].…”

“…Although no tissue damage was observed during these acute studies, chronic studies will be needed to confirm if tissue damage may result from sustained pacing over longer periods. Similar findings were reported from a series of chronic high frequency stimulation studies conducted on the proximal jejunum where localized intestinal contractions were induced in response to each stimulus [42]. Based on histological analysis reported in that study, electrical stimulation did not damage the stimulation site while suturing the electrodes caused mild inflammation and hemorrhage, which were not clinically significant [42].…”

Colonic Electrical Stimulation for Chronic Constipation: A Perspective Review

“…In almost all the studies, wire-based electrodes are used. We only found some studies using micromachined electrode arrays [ 13 , 89 , 90 ] directly placed on the colonic surface.…”

“…They all include options of bi-directional data transmission to adapt the stimulation parameters in open- and closed-loop control and to send out data to a patient-worn user interface ( Figure 3 a). Direct colonic electrical stimulation has been performed either by wire-based electrodes [ 69 ] that need to be distributed over the colon or by micromachined electrode arrays [ 89 , 90 ] directly placed on the colonic surface ( Figure 3 b). Direct stimulation needs relatively large amplitudes and pulse widths ( Table 1 ) to stimulate the smooth muscle cells of the colon.…”

Intestinal retentive systems – recent advances and emerging approaches

“…28,29 Therefore, there has been a growing interest in the bioelectronics community to develop non-invasive gut-interfacing electronics, which can permit the real-time monitoring of diagnostic indicators as well as the modulated release of therapeutic compounds. Research efforts in resident bioelectronics have been bolstered by the progression of miniaturized electronics, 30 biocompatible power supplies, [31][32][33] wireless power transmission, and novel biosensing pathways. 34,35 Early embodiments of this technology include smart pills such as PillCam, designed to image previously inaccessible diseased tissue sites and reduce the need for more invasive endoscopic procedures.…”