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Dexterity Enhancement for Flexible Endoscopic Interventional Tools

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44EB031741-01
Agency Tracking Number: R44EB031741
Amount: $724,531.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIBIB
Solicitation Number: PA20-260
Timeline
Solicitation Year: 2020
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-08-19
Award End Date (Contract End Date): 2023-07-31
Small Business Information
111 BROOKFIELD AVE
Nashville, TN 37205-4401
United States
DUNS: 081343728
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 JOSHUA GAFFORD
 (817) 320-3328
 joshua.b.gafford@vanderbilt.edu
Business Contact
 SCOTT WEBSTER
Phone: (706) 830-3471
Email: scott.webster@endotheia.com
Research Institution
N/A
Abstract

Project Summary/Abstract:
The objective of this proposal is to create a new low-cost transendoscopic laser/basket aiming tool that makes
ureteroscopic kidney stone removal easier for physicians, so that fewer patients require invasive surgery.
Clinical significance comes from the 230,000 patients per year (in the USA alone) with larger stone sizes,
for whom surgeons currently face a dilemma. They must either choose invasive surgery, or perform a lengthy
ureteroscopy which increases complication rates, and consumes excessive operating room time. Our central
hypothesis is that by increasing laser and basket dexterity, our new device will reduce the procedure time by
more than 25% for patients with larger stones. Achieving this would make many more patients candidates for
ureteroscopy; it will make it possible to remove larger stones almost as quickly as smaller stones are removed
today.
Innovation comes from harnessing elastic interactions in asymmetrically stiff, thin-walled tubes to create a
steerable aiming tip that is (1) small enough to pass through a standard ureterosocope port, while (2) carrying
a laser fiber or kidney stone basket within its open central lumen. The stiffness asymmetry of the tubes (which
are attached at their tips) transforms small axial motions applied at the endoscope handle into dexterous local
bending at the endoscope tip. The result is an inexpensive, disposable, luminal device for dexterously steering
laser fibers and kidney stone baskets, which is compatible with existing endoscopes, laser fibers, and baskets.
Our approach in Aim 1 is to build an OR-ready version of our device by using catheter-inspired tip design
processes with a surgeon interface amenable to practical, scalable manufacturing. Aim 2 incorporates rigorous
quality and human factors-based design enhancements and refinements so that our device is ready to undergo
the FDA 510(k) clearance process immediately at the end of Phase II. Aim 3 focuses on statistically powered
experiments to evaluate our hypotheses that our new steerable aiming tip will reduce average surgical duration by
25% – which will bring operative time for patients with larger stones in line with the current (small stone) standard
of care – and reduce maximum duration for many more large stone patients, bringing it to within clinical guidelines
for maximum safe ureteroscopy duration. Success in validating these hypotheses will strongly motivate future
Phase III activities (supported by private capital after the conclusion of this Phase II SBIR) where we complete
the FDA 510(k) clearance process, and launch our device on the market.Narrative: Public Health Relevance
Over 3.5 million Americans suffer from kidney stones each year, 230,000 of which have stones large enough that
surgeons face a dilemma: choose invasive surgery, or risk excessively long endoscopies with higher complication
rates and lose valuable operating room time. We propose a new low-cost, disposable device that passes through
a standard ureteroscope port and adds dexterity to lasers and baskets at the tip of the scope, making kidney
stone removal easier and more time efficient. Success in this research will make many more patients with larger
stones candidates for minimally invasive ureteroscopy.

* Information listed above is at the time of submission. *

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