Fecobionics device for mapping colonic and anorectal neuromuscular function

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ABSTRACT The colon and anorectum have complex composition. Methods to study neuromuscular interactions and activity in health and gastrointestinal (GI) disease have been limited due to difficult access and lack of appropriate technologies. Many aspects of colonic mechanosensory physiology are still not well understood including the influence of enteric circuits and reflexes, and extrinsic nerve function in the various segments of the colon. The need for new technology and a better understanding of the neuromuscular function is substantial. A significant problem is a lack of physiologically-relevant and practical test for identifying the underlying mechanism(s). Hence, the overall objective is to validate a fully integrative dynamic tool that mimics feces transport in the lower GI tract. Accordingly, the following tasks are proposed: 1) Optimization of a wireless development of Fecobionics device and System for neuromuscular function studies of the colon. Milestone: Wireless device that can record during transport through colon and anorectum; 2) Conduct safety and performance studies in dogs (including IDE approval): Milestone: Studies that demonstrates safety and performance of the device under different neuromuscular conditions; and 3) Develop a validated mathematical model of the lower GI tract. Milestone: Geometric and functional mathematical model for colonic transport and defecation. The proposed technology (Fecobionics) is a simulated electronic feces that has the consistency and shape of normal stool. The measured variables in Fecobionics include multiple pressures, shape changes, velocity and orientation. Hence, it will be feasible to map and describe objectively (without disturbing the colonic transport and defecation processes) the transport characteristics and neuromuscular signatures during colonic transport and initial entry from the rectum into the relaxing anal canal. This unique device will provide new neuromuscular signatures of the lower GI tract under normal circumstances, and during intervention with enteric and peripheral nerve activity to enhance our understanding of physiological and pathophysiological mechanisms involved in the lower GI tract neuromuscular function. In line with SPARC mission, we intend to provide a new technology for lower GI testing, simulating normal stool transport and defecation with a bionics device. This technology will replace several current tests, because it provides an integrated frame work for assessing function and obviates the need for multiple tests of function. The central premise is that a novel and unique Fecobionics device that mimics natural lower GI transport will provide new mechanistic insights regarding colonic and anorectal physiology when compared to standard tests and facilitate development of new diagnostics for lower GI disorders. The significance is to address the major gaps in knowledge by developing a safe, low cost, less invasive, low risk, radiation-free device, and test its ability to provide new understanding of colonic neuromuscular and defecation function. This may later facilitate development of diagnostic and therapeutic tools that will reduce healthcare costs.