Project Summary/Abstract
The objective of this proposal is to create dexterous steerable instrument sheaths that enable patients who
currently are subject to invasive surgeries to receive minimally invasive endoscopic interventions.
Clinical significance comes from (1) the high incidence of colon lesions – there are 6.3 million colonoscopies
per year with 50% finding lesions, and (2) the difficulty of removing a subset of these (those with challenging
sizes, shapes, or locations) due to the limited dexterity of conventional endoscopes. This results in over 60,000
patients per year in the USA with colon lesions that the very best endoscopists have demonstrated can be safely
removed with an outpatient endoscopic procedure, who are instead subjected to invasive surgery to remove
a section of their colon (i.e. colectomy surgery). This occurs because of the dexterity gap between the best
endoscopists and typical endoscopists. We aim to close this gap with the new device described in this proposal.
The innovation in our work is a new steerable sheath concept that harnesses elastic asymmetry to provide
dexterity at the tip of a colonoscope. This dexterity reduces the difficulty of removing challenging lesions endo-
scopically. Our controllably deflectable, thin-walled, tube-like device will be small enough to pass through the
port of a conventional endoscope, while providing a large open lumen for surgical instruments to pass through.
Its innovative mechanical design accomplishes this by dispensing with conventional pull-wires, hinges, and other
bulky force transmission elements in favor of the push-pull interaction of two thin-walled tubes, which bend con-
trollably via interacting regions of stiffness asymmetry at their tips.
Our approach consists of three Specific Aims. Aim 1 addresses the construction of the steerable sheaths and
their actuation systems. Aim 2 focuses on enabling dexterous physician control via a physician interface console,
and optimization of device dexterity. Aim 3 consists of ex vivo and in vivo porcine experiments to demonstrate
that the device enables physicians new to endoscopic dissection to perform with accuracy and efficiency similar
to what elite endoscopists have shown can effectively and safely treat the 60,000 patients mentioned above. The
endpoint of this project will be a device that has been validated in an animal model, setting the stage for rapid
clinical translation after successful completion of this R01.
