Intestinal Manometry Force Sensor for Robotic Capsule Endoscopy: An Acute, Multipatient In vivo Animal and Human Study

Goal: Development of a new medical device class generally termed robotic capsule endoscopes (RCE) is currently being pursued by multiple research groups. These maneuverable devices will allow minimally invasive diagnosis and treatment of intestinal pathologies. While the intraluminal pressures related to the migrating motor complex (MMC) are well understood, no previous study has measured the active contact forces exerted by the human small bowel wall on a solid, or near solid bolus such as an RCE. Understanding and quantifying the active contact force are critical for the advancement of RCE technology. Methods: In this study, the authors develop a novel manometric contact force sensor for human studies and validate the feasibility of the design, sterilization method, and minimally invasive surgical procedure in a multianimal study, followed by a multihuman study. Results: Four porcine tests of the sensor were conducted. The mean porcine myenteric contact force measured using the new sensor is 1.20 ± 0.08 N·cm^-1. The mean myenteric contact force recorded for all five human test subjects is 0.18 ± 0.33 N·cm^-1. Conclusion: This study demonstrates the feasibility of operating an MMC force sensor in a live human with a minimally invasive surgical technique and presents force data necessary for RCE design. Significance: This study represents the first known myenteric contact force measurements on a solid bolus in the human small intestine.