Intelligent feces – Hope for patients with constipation and fecal incontinence symptoms.


Path to FDA approval of SPARC supported diagnostic test of defecatory function in patients with constipation or fecal incontinence.

The Problem

Anorectal disorders including constipation and fecal incontinence affect 15-25% of the population but are difficult to diagnose and subtype. A variety of tests exist but they show conflicting results, including many false positives, and do not correlate well with the symptoms experienced by the patients.

The Solution

Based on the above-mentioned deficiencies, we developed a new device that integrates most current tests and provides an objective, safe and low-cost assessment of defecatory function. The device named Fecobionics is a simulated feces, 10cm long and with a fillable bag. It measures a variety of parameters during defecation of the device including pressures, bending, and shape changes. The data can be used for advanced modeling of anorectal function.

Prototypes of Fecobionics have been validated and have shown very convincing results in human testing. Distinct differences in patterns (phenotypes) have been demonstrated between normal subjects and patients with constipation and fecal incontinence. More than 120 subjects have been studied with early prototypes and patient subtypes have been identified. An application for use as a diagnostic tool in clinical care will be submitted to the FDA later this year.

Fig1

Figure 1. Sketches of Fecobionics device. (Top) The system with the Fecobionics device, the syringe to fill the bag, and the computer for data transmission and power supply. (Bottom) Fecobionics inside the rectum with pressure sensors placed at the front, rear, and inside the bag. The front pressure sensor measures initially from the upper anal canal, whereas the bag and rear pressure sensors measure the rectal pressure.

Fecobionics

Figure 2. The graphical user interface showing pressures, bending, orientation and shape changes during defecation.

Impact

Fecobionics is expected to improve diagnostics and subtyping of constipation and fecal incontinence.

Other applications include:

  • Evaluation of colon function. Fecobionics has already been utilized to improve our understanding of colon neuromuscular function and colon transit. Previously unrecognized contraction waves have been obtained in live dogs. Fecobionics could be used to provide partial colon sparing colectomy for severe constipation.

  • Biofeedback therapy for constipation and fecal incontinence. Fecobionics can be used for biofeedback at the point-of-care (in the home of patients), improving care while saving cost and resources in the health care system.

  • Evaluation of the effect of sacral nerve stimulation (SNS) efficiency. Recording the anorectal impact of sacral nerve stimulation in patients with severe fecal incontinence using Fecobionics is expected to provide new information about SNS mechanisms.

Credits to members of the team at California Medical Innovations Institute, San Diego, CA.

Author
Hans Gregersen, MD, PhD

Team Members

California Medical Innovations Institute

PI: Hans Gregersen, MD, PhD ORCID iD: 0000-0002-5792-2845

Ghassan Kassab, PhD ORCID iD: 0000-0001-7126-1484

Bhavesh Patel, PhD ORCID iD: 0000-0002-0307-262X


Supporting information

Gregersen H. Novel Bionics Assessment of Anorectal Mechanosensory Physiology. Bioengineering (Basel). 2020;7(4):146. https://doi.org/10.3390/bioengineering7040146

Gregersen H, Chen SC, Leung WW, Wong C, Mak T, Ng S, Daming S, Futaba K. Characterization of Patients With Obstructed Defecation and Slow Transit Constipation With a Simulated Stool. Clin Transl Gastroenterol. 2021;12(5):e00354. https://doi.org/10.14309/ctg.0000000000000354

Gregersen H, Wang Y, Guo X, Field F, Nelson M, Combs W, Wang M, Kassab G. Simulated Colonic Feces Reveals Novel Contraction Patterns. Gastroenterology. 2021;160(3):660-662. https://doi.org/10.1053/j.gastro.2020.09.055

NIH Support: OT2OD025308, Fecobionics device for mapping colonic and anorectal neuromuscular function, https://reporter.nih.gov/search/9P1PP0HKJUuuUlXFvPS2kQ/project-details/10227270


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