Abstract
Abstract Impairment of Eustachian tube function with nonsufficient ventilation of the middle ear is a main cause for chronic otitis media. To provide an effective and safe therapy, the innovative concept of Eustachian tube stenting was established. Biodegradable polymeric stents are developed to restore impaired tube function and dissolve after fulfilling their supportive purpose. To evaluate the applicability of the stents in the Eustachian tube, prototypes in conjunction with corresponding implantation instruments were tested in human cadaver studies. Radiopaque markers and a diaphanoscopic approach were tested as additional features to prove correct positioning of catheter and stent in the tube. In the current study biodegradable polymeric stents were implanted in the Eustachian tube of human cadavers without difficulty. Correct positioning of the stents in the tube was proved by diaphanoscopy during intervention and postoperative tomographic and histological analyses. Once designs are optimized on the basis of cadaver studies, preclinical safety and efficacy studies using animal models will be initiated.
Highlights
Eustachian tube dysfunction (ETD) with non-sufficient ventilation of the middle ear may, among other things, lead to chronic otitis media
The visibility of the stents by means of the integrated radiopaque markers could be proved in postprocedural computer tomography (CT) images (Figure 5)
In follow-up to the application tests executed histological analyses showed, that the polymeric stents effectuate an opening of the Eustachian tube and adapt to the tube geometry of without generating a complete circular crosssection
Summary
Eustachian tube dysfunction (ETD) with non-sufficient ventilation of the middle ear may, among other things, lead to chronic otitis media. Prevalence of chronic ETD is about 1 % of adult population and is the main cause of permanent conductive hearing loss [1, 2]. Stenting of the Eustachian tube as treatment option is an innovative concept to restore impaired tube function. Besides development and testing of permanent stents, we pursue concepts of biodegradable stents. Assuming the supporting effect of Eustachian tube stents is required only temporarily, the stents dissolve afterwards leaving no foreign body behind. Following cardiovascular stent technologies poly(L-lactide) (PLLA) or PLLA-based blends are considered as materials for biodegradable Eustachian tube stents
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