ENDOTHEIA INC — Department of Health and Human Services STTR Phase I: NIBIB

Description

Project Summary AbstractThe objective of this proposal is to perform proof of concept experiments for a new thin walledsteerable sheath that can pass through a standard colonoscope port and dexterously maneuver surgical instruments at its tipClinical significance comes from the fact that overpatients per year in the USA have unnecessaryinvasive surgery to remove a section of their colonClinical literature shows that these lesions can and should be removed in an outpatient endoscopic settingbut the dexterity limitations of conventional endoscopes make the procedures challenging for the physicianleading to excessive surgical referralsThese patients could be spared invasive surgery if physicians had the dexterous instruments we seek to createThe innovation in our work is a new steerable sheath concept small enough to pass through a standardcolonoscope portwhile maintaining an open lumen within itself large enough to carry transendoscopic surgicalinstrumentsIts innovative mechanical design harnesses the stiffness asymmetry of two elastically interacting thin walled tubesto enable the physician to precisely control surgical instruments at the endoscopeandapos s tipOur approach in Aimis to create prototypes of our new sheath conceptIn Aimwe design a surgeon control handle that facilitates intuitive operation of the steerable sheathThe handle will include a motor that enables us to create many linear and nonlinear handle tip mappings in softwareso that mechanical iteration is not requiredThis will enable us to converge rapidly on the best design for our productwhich will use a fully mechanicali enon roboticsurgeon control handleAimfocuses on statistically powered experiments that evaluate our hypothesis that the new steerable sheath will enable novices to perform with expert level efficiency and margin quality in ex vivo porcine colon resectionsSuccess in these experiments will strongly motivate the development of a biocompatiblesterilizable steerable sheath product in the context of a follow on Phase II project NarrativePublic Health Relevance Overpatients per year have invasive surgery to remove a section of their coloneven though their lesions canin principlebe safely removed much less invasively via a colonoscopic interventionThe primary reason for theseunnecessarysurgeries is the lack of dexterity of conventional endoscopeswhich makes the procedures so challenging that only a few of the very best endoscopists can perform themTo remedy thiswe propose a new tiny steerable sheath created by harnessing stiffness asymmetry encoded into the material properties of the sheath itselfwhich will provide unprecedented dexterity for physicians