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An Ultra-Thin Steerable Transnasal Endoscope to Replace Exploratory Middle Ear Surgeries

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44DC019894-01
Agency Tracking Number: R44DC019894
Amount: $1,383,797.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIDCD
Solicitation Number: PA20-260
Solicitation Year: 2020
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-08-13
Award End Date (Contract End Date): 2023-07-31
Small Business Information
Nashville, TN 37205-4401
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 low-cost, needle-sized steerable endoscope that makes it
possible to survey and diagnose middle ear disease using a minimally-invasive trans-Eustachian tube approach,
sparing patients from invasive surgery.
Clinical significance comes from the 84,000 surgeries per year (in the USA alone) performed on patients who
suffer from a middle ear disease called cholesteatoma that requires exploratory surgery for diagnosis, which is
currently achieved surgically by lifting the eardrum to expose the middle ear space. Surgery is currently the only
definitive way to diagnose these patients. Worse yet, a second surgery is performed to check for recurrence
a year later – even though 67% of patients will be disease free at that time. We seek to replace surgical
inspection with a simple endoscopy, facilitated by our new ultra-thin steerable endoscope passed through the
Eustachian tube. Our central hypothesis is that our new trans-tubal endoscopic approach can achieve diagnostic
visualization of the middle ear equivalent to that provided by surgery today. This has the potential to spare many
patients from the pain and complications associated with surgery, by replacing it with a simple endoscopy done
through the nose.
Innovation comes from harnessing elastic interactions in asymmetrically stiff, thin-walled tubes to create a
steerable endoscope that is (1) small enough to pass through the Eustachian tube, while (2) carrying a tiny
camera and optical illumination fibers within its own central lumen. The small diameter of the Eustachian tube
precludes the use of bulky standard endoscope steering mechanisms. Instead, we harness stiffness asymmetry
encoded into the material properties of two tubes that are attached at their tips, thereby transforming small axial
motions applied at the endoscope handle into dexterous local bending at the endoscope tip. The result is an
inexpensive, needle-sized, disposable, steerable endoscope for trans-tubal visualization of the middle ear.
Our approach in Aim 1 is to use laser micromanufacturing and catheter-inspired design processes to fabricate
a clinic-ready steerable endoscope tip with integrated imaging and illumination. Aim 2 incorporates rigorous
quality and human factors-based design enhancements, preparing our device for FDA 510(k) clearance review
immediately at the end of Phase II. Aim 3 focuses on statistically powered experiments to evaluate our hypothesis
that our new steerable aiming tip will enable middle ear inspection and cholesteatoma diagnoses to be performed
using a non-surgical, trans-Eustachian tube approach, with equal diagnostic-quality visual coverage compared
to the surgical standard-of-care. 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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