Current flexible endoscopes have limited dexterity and sensor feedback, making navigation in colonoscopy a challenging task. These technical limitations make screening procedures poorly tolerated by patients, leading to low rates of compliance with screening guidelines and/or incomplete colonoscopy, that is associated with higher rates of interval proximal colon cancer. Alternative engineering solutions have been proposed for robotically-assisted colonoscopy, which are based on cable-driven mechanisms, motorized spiral colonoscopy, or pneumatic systems. However, a major drawback of such approaches is uncontrollability of the tension to the colon wall caused by the lack of tactile feedback to the endoscopists. The overall goal of this proposal is to advance current navigation capabilities of endoscopic platforms to enhance diagnosis and therapy. This project aims at exploring the use of a soft robotic sleeve that can be wrapped around current endoscopic instrumentation to provide sensor feedback and actuation capabilities that can improve navigation in colonoscopy, avoiding the necessity for dedicated or customized instruments and without disrupting the current surgical workflow. Furthermore, we propose to integrate bleeding detection and coagulation capabilities in the device by merging soft robotics and microfluidic technologies to effectively perform intraoperative diagnosis and therapy, enabling surgeons to modify their approaches at the time of surgery and decide on further plan of management. Distributed soft optical sensors will monitor the pressure exerted by the colonoscope onto tissue during navigation and if excessive pressure is detected, the soft actuators will be inflated to guarantee pressure redistribution and aid navigation, while safely anchoring, stabilizing, and reorienting the motion of the colonoscope in comparison with standard endoscopic systems. This device will be manufactured using biocompatible soft elastomers and gels exploiting advanced manufacturing techniques, such as laser precision micromachining, replica-based micro fabrication techniques, and multi-layer lamination through chemical surface modification. The Investigative Team, combining engineering and clinical faculty from Boston University (Mechanical Engineering Department) and Harvard University (Brigham and Women?s Hospital), is uniquely positioned to achieve the success of this study. Specifically, the Investigators collectively possess expertise in endoscopic device design, clinical colonoscopy, and assessment and validation of innovative gastrointestinal technologies. We hypothesize that this soft robotic sleeve will provide the superior ability to perform endoscopic navigation inside body cavities (i.e., the intestine) in a safer, easier, and smoother way.

Public Health Relevance

This project aims at developing a first demonstration of a soft robotic sleeve with highly integrated and distributed sensing and actuation elements, that can enable safer and easier navigation tasks in colonoscopy, and a diagnostic and therapeutic tool based on microfluidic technology to enable bleeding detection and coagulation. This has the potential to pave the way for novel approaches in diagnosis and therapy in endoscopic surgery, higher colonoscopy completion rate, shorter novice surgeons? learning curves, and lower patients? discomfort.

Agency
National Institute of Health (NIH)
Institute
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21EB029154-01
Application #
9876723
Study Section
Bioengineering, Technology and Surgical Sciences Study Section (BTSS)
Program Officer
Wolfson, Michael
Project Start
2020-09-18
Project End
2023-09-17
Budget Start
2020-09-18
Budget End
2023-09-17
Support Year
1
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Boston University
Department
Engineering (All Types)
Type
Biomed Engr/Col Engr/Engr Sta
DUNS #
049435266
City
Boston
State
MA
Country
United States
Zip Code
02215