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Tendon‐like tether formation for tongue‐base advancement in an ovine model using a novel implant device intended for the surgical management of obstructive sleep apnoea
Author(s) -
Hendricks Rushdi,
Hofmann Elena,
Peres Jade,
Prince Sharon,
Hille Jos,
Davies Neil H.,
Bezuidenhout Deon
Publication year - 2021
Publication title -
journal of biomedical materials research part b: applied biomaterials
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.665
H-Index - 108
eISSN - 1552-4981
pISSN - 1552-4973
DOI - 10.1002/jbm.b.34765
Subject(s) - implant , polydioxanone , airway , materials science , continuous positive airway pressure , medicine , biomedical engineering , dentistry , surgery , obstructive sleep apnea
Obstructive sleep apnoea (OSA) is a serious debilitating condition with significant morbidity and mortality affecting almost one billion adults globally. The current gold standard in the non‐surgical management of airway collapse is continuous positive airway pressure (CPAP). However, non‐compliance leads to a high abandon rate (27–46%). While there are multiple sites of airway obstruction during sleep, the tongue base is recognized as the key player in the pathogenesis of OSA. Poor outcomes of current tongue suspension devices are due to fracture, slippage or migration of devices. Three tongue tethering device groups, namely a polydioxanone/polyurethane combination (PDO + PU) treatment group, a PDO analytical control group, and a polypropylene (PP) descriptive control group, were implanted into 22 sheep (75–85 kg) in a two‐phased study. After implant times of 8, 16, and 32 weeks, sheep were serially euthanized to allow for explantation of their tongues and chins. The PDO + PU devices remodeled during the 32‐week implant period into a hybrid biological tendon‐like tether through the process of gradual degradation of the PDO and collagen deposition as shown by electrophoresis, histology and mechanical testing. The control PDO device degraded completely after 32 weeks and the PP devices remained intact. The hybrid biological tendon‐like tether exhibited a break‐strength of 60 N, thus exceeding the maximum force to overcome upper airway collapse.