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Breaking the Scope Port Size Barrier: A New Kind of Endoscope that Removes Large Kidney Stones Rapidly

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44DK137695-01
Agency Tracking Number: R44DK137695
Amount: $929,229.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 400
Solicitation Number: PA22-176
Solicitation Year: 2022
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-08-01
Award End Date (Contract End Date): 2025-06-30
Small Business Information
Nashville, TN 37205
United States
DUNS: 081343728
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (817) 320-3328
Business Contact
Phone: (706) 830-3471
Research Institution

Project Summary/Abstract:
The objective of this proposal is to create a new kind of flexible ureteroscope that transforms nearly instanta-
neously from endoscope to large-lumen steerable suction catheter to enable rapid removal of large kidney stone
volumes, sparing patients from invasive alternatives.
Clinical significance comes from the 3.5 million patients who suffer from kidney stones each year in the
USA alone, 700,000 of whom have interventional procedures done to remove the stones. 230,000 of these
people have larger kidney stone volumes, and thus are subject to either invasive surgery or excessively long
ureteroscopy, with its increased complication rates and excessive procedure durations. Our central hypothesis is
that our new transformable ureteroscope will reduce the procedure time by 36 minutes or more for patients with
large stone volumes. Reducing procedure duration by this much will make larger stone times equivalent to small
stone times, making many more patients candidates for minimally invasive interventions.
Innovation comes from a new mechanical actuation concept that enables us to build bending actuation directly
into the outer wall of the device itself. This enables an open central lumen that is nearly as large in diameter
as the endoscope itself. The lumen initially carries a camera/illumination core that can be removed whenever
desired to transform the device into a steerable suction sheath. To build bending actuation into the outer wall,
we harness elastic interactions in asymmetrically stiff, thin-walled tubes. After attaching these tubes at their tips,
tip bending can be created through small relative linear displacement at the tube bases. The result is a highly
dexterous device with the same bending capabilities of a ureteroscope that has a large central lumen for high
volume stone removal via suction.
Our approach in Aim 1 is to design, optimize and build an OR-ready version of our steerable sheath and
insertable camera/illumination core using scalable manufacturing processes and clinical-grade, biocompatible
materials. The goal of Aim 2 is to create the user interface of the steerable section and the removable cam-
era module, culminating in a low-volume production run with production-equivalent materials, and to perform
comprehensive formative human factors evaluations of the Aspire system. Aim 3 focuses on statistically pow-
ered experiments to evaluate our hypotheses that our new steerable suction scope will reduce average surgical
duration by 38%, while also demonstrating a reduction in surgical duration of very large stones and improv-
ing stone-free rates. This will bring times and stone free rates for patients with larger stones in line with the
current (small stone) standard of care, so that they can be treated 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.

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

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