A robotic enteroscope for safe and effective access to the small bowel

Abstract Drive Medical is developing the Pollywog , a robotic enteroscope that enables gastroenterologists of all skill levels to access the small intestine easily and quickly. Problems with the small intestine can include bleeding, Celiac disease, Crohn’s disease, infections, inflammation, polyps, and cancer. Patients suspected of having a small intestine disorder must be referred to a highly skilled gastroenterologist who can perform a deep enteroscopy to visualize the small bowel. Deep enteroscopy is a highly complex procedure, given the shear length that an endoscope must be advanced into the intestine, anatomical complexity of the small intestine, and the anatomical variation between patients. Unfortunately, deep enteroscopy is the only procedure that allows for a comprehensive small intestine examination – less labor-intensive alternative options, including capsule endoscopy, make precise location of intestinal areas of interest difficult, and unable to provide tissue sampling and interventions, thus limiting the usefulness of any findings. As such, Drive Medical is developing a device that enables gastroenterologists of any skill level to perform examinations and procedures in the small bowel. The Pollywog is a disposable soft robotic endoscope that uses a self-driven double balloon mechanism that inches through the full length of the small and large intestines. Since the Pollywog uses technology that allows it to crawl through the intestine, the movement mechanism of action resembles pulling, rather than pushing (like traditional deep enteroscopy methods). The Pollywog’s self-driven crawling mechanism enables fast intubation speed while avoiding trauma to the luminal wall, thus reducing the need for sedation and making perforations less likely when enteroscopy is being performed by gastroenterologists of all skill levels. With its deep intubation capability and intervention channel, the Pollywog is a key enabling technology for multiple indications that are related to small intestine disorders. In Phase I, Drive Medical seeks to demonstrate that the Pollywog achieves access to the small intestine without increased patient risk, and show that less skilled gastroenterologists can quickly achieve access and navigate the small intestine. This will confirm the feasibility of the Pollywog to enable more gastroenterologists to adequately perform deep enteroscopy without increasing risk. The specific aims of this Phase I project are: 1) Develop a functional Pollywog navigation system and confirm risk-minimal functionality and 2) Perform a usability study with GIs to confirm that the Pollywog lowers the barrier to accessing the small bowel compared to double balloon enteroscopy. This work will set up a Phase II in which Drive Medical can use the gastroenterologists’ feedback to make design changes and then begin safety and efficacy testing to use for a regulatory submission. Further proposals would explore the performance of the Pollywog under multiple disease states, thus validating the ability of the Pollywog to increase access to care for patients with a variety of small intestine disorders.