Vocal Fold Augmentation with Injectable Polycaprolactone Microspheres/Pluronic F127 Hydrogel: Long-Term In Vivo Study for the Treatment of Glottal Insufficiency

Abstract

There is increasing demand for reconstruction of glottal insufficiency. Several injection materials have been examined for this purpose, but all had limitations, such as poor long-term durability, migration from the injection site, inflammation, granuloma formation, and interference with vocal fold vibration due to viscoelastic mismatch. Here, we developed a novel injection material, consisting of polycaprolactone (PCL) microspheres, which exhibits better viscoelasticity than conventional materials, and Pluronic F127 carrier, which decreases the migration of the injection materials. The material was injected into rabbits with glottal insufficiency and compared with the FDA-approved injection material, calcium hydroxylapatite (CaHA). Endoscopic and histological examinations indicated that PCL/Pluronic F127 remained at the injection site with no inflammatory response or granuloma formation, whereas CaHA leaked out and migrated from the injection site. Therefore, vocal fold augmentation was almost completely retained during the 12-month follow-up period in this study. Moreover, induced phonation and high-speed recording of vocal fold vibration showed decreased vocal fold gap area in the PCL/Pluronic F127 group. Our newly developed injection material, PCL/Pluronic F127, permits efficient augmentation of paralyzed vocal fold without complications, a concept that can be applied clinically, as demonstrated by the successful long-term follow-up.

Preparation and evaluation of icariside II-loaded binary mixed micelles using Solutol HS15 and Pluronic F127 as carriers

“…In the present study, we developed a novel SF-IS mixed micelle composed of HS15 and F127, aiming to improve the poor absorption of IS. F127 was selected to prepare the micelles due to its biocompatibility and its approval by the FDA (Kwon et al, 2014). HS15 has several advantages, such as a good solubilizing effect, high stability, and low toxicity.…”

Preliminary results of tissue‐engineered injection laryngoplasty material in a rabbit model

“…In 2013 and 2014, Kwon et al published short‐ and long‐term results of IL utilizing PCL microspheres. They were able to demonstrate excellent volume retention of material after 12 months and a small amount of inflammatory reaction to the injection in a rabbit model . Their study did not note any material migration over time in the PCL group.…”

Poly(lactic-co-glycolic) acid microspheres encapsulated in Pluronic F-127 prolong hirudin delivery and improve functional recovery from a demyelination lesion

“…[29] It has therefore been used as an injected carrier with microspheres for better retention at the site of injection. [30] Based on this previous work, we hypothesized that cargo release from PLGA microspheres may be further sustained by co-injection with Pluronic F-127. Due to the cost of recombinant hirudin, initial release studies were conducted using model protein albumin and heparin.…”