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Development of a microporous annealed particle hydrogel for long‐term vocal fold augmentation
Author(s) -
Pruett Lauren,
Koehn Heather,
Martz Teresa,
Churnin Ian,
Ferrante Sergio,
Salopek Lisa,
Cottler Patrick,
Griffin Donald R.,
Daniero James J.
Publication year - 2020
Publication title -
the laryngoscope
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.181
H-Index - 148
eISSN - 1531-4995
pISSN - 0023-852X
DOI - 10.1002/lary.28442
Subject(s) - medicine , biomedical engineering , immunogenicity , implant , biomaterial , hyaluronic acid , scaffold , surgery , anatomy , immune system , immunology
Objectives/Hypothesis The purpose of this study was to develop and provide evidence of a novel permanent injectable biomaterial for vocal fold augmentation with the potential to treat glottic incompetence by evaluating its performance in two animal models. Study Design Animal model. Methods Microporous annealed particle (MAP) hydrogel was fabricated using a water‐in‐oil emulsion method and synthetically tuned to match the stiffness modulus of native vocalis muscle. Thirty‐two New Zealand White rabbits were administered unilateral injections of MAP (n = 16), saline (n = 8), and the clinical standard hyaluronic acid (Restylane‐L) (n = 8), and evaluated at day 0, and 6‐week, 4‐month, and 6‐month endpoints. Induced vocal fold vibration was recorded with a high‐speed camera prior to euthanization, with glottic closure and mucosal wave characteristics assessed both quantitatively and qualitatively by an experienced voice clinician. Histologic analysis was performed to assess scaffold permanence, immunogenicity, and vascularization within the scaffold. Results Histologic analysis confirmed the MAP gel treatment group maintained its volume without migration for 6 months postimplantation. Immune staining showed minimal to nonexistent immunogenicity over the course of the implant lifetime. Extensive tissue integration and vascularization was observed histologically within the MAP gel group by immunofluorescence staining. Mucosal wave was not impaired by any of the injected materials, including the MAP gel augmentation. Conclusions MAP gel is a nonresorbable biostimulatory injectable implant that provides superior tissue integration, stiffness matching, and permanence compared to current injectable implants, with retained biomechanical function, suggesting its potential as a new therapeutic for glottic incompetence. Level of Evidence NA Laryngoscope , 130:2432–2441, 2020