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Eyes in Ears: A Miniature Steerable Digital Endoscope for Trans-Nasal Diagnosis of Middle Ear Disease

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Abstract

The aim of this work is to design, fabricate and experimentally validate a miniature steerable digital endoscope that can provide comprehensive, high-resolution imaging of the middle ear using a trans-nasal approach. The motivation for this work comes from the high incidence of middle ear diseases, and the current reliance on invasive surgery to diagnose and survey these diseases which typically consists of the eardrum being lifted surgically to directly visualize the middle ear using a trans-canal approach. To enable less-invasive diagnosis and surveillance of middle ear disease, we propose an endoscope that is small enough to pass into the middle ear through the Eustachian tube, with a steerable tip that carries a 1 Megapixel image sensor and fiber-optic illumination to provide high-resolution visualization of critical middle ear structures. The proposed endoscope would enable physicians to diagnose middle ear disease using a non-surgical trans-nasal approach instead, enabling such procedures to be performed in an office setting and greatly reducing invasiveness for the patient. In this work, the computational design of the steerable tip based on computed tomography models of real human middle ear anatomy is presented, and these results informed the fabrication of a clinical-scale steerable endoscope prototype. The prototype was used in a pilot study in three cadaveric temporal bone specimens, where high-quality middle ear visualization was achieved as determined by an unbiased cohort of otolaryngologists. This is the first paper to demonstrate cadaveric validation of a digital, steerable, clinical-scale endoscope for middle ear disease diagnosis, and the experimental results illustrate that the endoscope enables the visualization of critical middle ear structures (such as the epitympanum or sinus tympani) that were seldom or never visualized in prior published trans-Eustachian tube endoscopy feasibility studies.

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Acknowledgments

The authors would like to acknowledge Enable, Inc. for assisting in the design, development, and fabrication of the steerable endoscope presented in this work.

Funding

The authors thank the National Institutes of Health (NIH) for Grant R21 DC016153-01A1 which supported the work described in this paper. Any opinions, findings, and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the National Institutes of Health. Role of Sponsors: The sponsors had no role in the design of the study, the collection and analysis of the data, or the preparation of the manuscript.

Conflict of interest

The authors have no conflicts of interest to report.

Ethical Approval

All temporal bone experiments were performed under the supervision of a single otolaryngologist (M.F.). All cadaver specimens were obtained from Vanderbilt University Medical Center, and their use falls under IRB Exemption according to 45 CFR 46. We did not recruit a multiple-user cohort to perform these pilot experiments. Recruitment of subjects for the purposes of Likert survey data collection was performed under the approved IRB protocol 200449. The computer simulations run on patient models were deemed exempt from the Worcester Polytechnic Institute IRB pursuant to 45 CFR 46.101(b). Based on these consideration, and the fact that no live patients or live animals were involved in our experiments, prior approval from an ethics committee (IRB or IACUC) was not required.

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Authors and Affiliations

  1. Vanderbilt University Engineering Department, Nashville, TN, USA

    Joshua Gafford, Jack Noble & Robert J. Webster III

  2. Worcester Polytechnic Institute, Worcester, MA, USA

    Loris Fichera

  3. Vanderbilt University Medical Center, Nashville, TN, USA

    Michael Freeman, Robert Labadie & Robert J. Webster III

  4. Vanderbilt Institute for Surgery and Engineering (VISE), Nashville, TN, USA

    Jack Noble, Robert Labadie & Robert J. Webster III

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  1. Joshua Gafford
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  2. Michael Freeman
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Correspondence to Joshua Gafford.

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Associate Editor Ka-Wai Kwok oversaw the review of this article.

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Gafford, J., Freeman, M., Fichera, L. et al. Eyes in Ears: A Miniature Steerable Digital Endoscope for Trans-Nasal Diagnosis of Middle Ear Disease. Ann Biomed Eng 49, 219–232 (2021). https://doi.org/10.1007/s10439-020-02518-9

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  • DOI: https://doi.org/10.1007/s10439-020-02518-9

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