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A new absorbable pressure-equalizing tube.

Riccardo D'eredità1, Roger R Marsh, Silvano Lora

  • 1Division of Pediatric Otolaryngology, The Children's Hospital of Philadelphia, and the Institute of Photochemistry and High Energy Radiation, National Institute of Nuclear Energy, Legnaro, Padua, Italy. rderedita@hotmail.com

Otolaryngology--Head and Neck Surgery : Official Journal of American Academy of Otolaryngology-Head and Neck Surgery
|August 6, 2002
PubMed
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New biodegradable poly-bis(ethylanate)phosphazene (PBE) pressure-equalizing (PE) tubes showed no adverse reactions in an animal model. These promising PBE PE tubes demonstrate controllable disintegration for potential clinical applications.

Area of Science:

  • Biomaterials Science
  • Otolaryngology
  • Polymer Chemistry

Background:

  • Middle ear infections often require pressure-equalizing (PE) tubes to ventilate the middle ear.
  • Current PE tubes are typically made of non-absorbable materials, necessitating removal.
  • Biodegradable materials offer a potential alternative for temporary middle ear ventilation.

Purpose of the Study:

  • To evaluate the biocompatibility and degradation of novel poly-bis(ethylanate)phosphazene (PBE) based pressure-equalizing (PE) tubes.
  • To assess the in vivo performance and tissue response to PBE-PE tubes in an animal model.

Main Methods:

  • PBE-PE tubes were implanted in 55 ears of 28 Hartley guinea pigs.
  • Animals were observed for 10, 30, and 60 days post-implantation.

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  • Histological and microscopy analyses (light and scanning electron) were performed on tubes, tympanic membranes, and middle ear tissues.

    • Main Results:

    • No infections or inflammatory reactions were observed in the middle ears.
    • Complete or partial disintegration of PBE-PE tubes occurred in 53% of cases by 30 days.
    • Functional patency of PBE-PE tubes was maintained in 25% of ears at 60 days.

    Conclusions:

    • PBE-PE tubes are biocompatible and show promising degradation characteristics in an animal model.
    • The disintegration rate of PBE-PE tubes can be modulated by altering the polymer formulation.
    • Further research is warranted before clinical application of these biodegradable PE tubes.