SPARC: Wireless Fecobionics Device in dogs

Objective We developed a novel wireless device (Fecobionics) for mapping colonic and anorectal neuromuscular function. Fecobionics measures pressures, cross‐sectional areas and bending of the device and transmits data wireless to a receiver unit outside the body (figure 1). This study evaluated the safety of the device in dogs relative to the predicate THD SensyProbe device for biofeedback. Furthermore, physiological data were obtained with Fecobionics. Methods Twelve male Mongrel dogs with 25kg body weight were assigned into two groups: Fecobionics group and predicate control group (N=6 of each). Fecobionics and the predicate device were transanally inserted into rectum. Further, each group was divided into two sub‐groups: The acute group in which the animals were euthanized immediately after the evacuation of the device, and the chronic group in which the animals were terminated after 2 weeks. The animals were monitored daily. Tissue from different colon segments and anorectum were collected after the dogs were euthanized. HE staining and immunofluorescence staining were performed. Results All procedures were performed successfully without complications. All chronic animals showed normal food intake and behavior after the procedure. Wireless transmission of Fecobionics data were without significant data loss or data error. Fecobionics studies demonstrated defecation pressures in the range 60–100cmH 2 O. The bending of the device, representative of the anorectal angle, was less than 30 degrees. The shape of the bag was obtained from the serial cross‐sectional area measurements. The shape of Fecobionics was cylindrical in rectum and changed to hourglass shape when it passed through the anal canal. No signs of inflammation were identified in the tissue sections examined histologically or immunohistochemically (macrophages and caspase‐3) in both Fecobionics and control groups. Conclusions Wireless Fecobionics is as safe as the predicate device, without inducing macro‐ or microscopic changes or inflammatory status of anorectal muscle. Novel physiological data were obtained. Dogs seems not to have an anorectal angle like humans, which makes defecatory efficacy more dependent on intrarectal pressure and anal sphincter relaxation compared to humans. Support or Funding Information Funding NIH SPARC OT2OD025308The Fecobionics device (left), the wireless receiver (middle) and the data collection device (right).