The presented three different balloon dilation devices for treating Eustachian tube dysfunction were compared regarding their geometries and designs. The balloon dilation behaviour was investigated by an in vitro test setup consisting of a test chamber with 37 °C water, a 2-axis laser scanner and a pressure controller. All balloons could be properly dilated up to the given nominal pressure (NP) or to rated burst pressure (RBP). The balloons reached their expected balloon diameter and length. The compliance data were 1.07 %/atm (TubaVent short), 1.16 %/atm (Acclarent Aera) and 1.28 %/atm (XprESS LoProfile). The measured profile and compliance data can be used for development of new devices for balloon dilation Eustachian tuboplasty.
To provide an effective and safe therapy for chronic Eustachian tube dysfunction (ETD), biodegradable stents should be developed to restore important functions, e.g. middle ear ventilation and drainage. After defining general requirements specifications, stent designs of cardiovascular polymeric stents were modified according to dimensions and conditions of the Eustachian tube. Finite element simulations demonstrated the crimping capacity of the developed stent design and the ability of expansion in the specific geometry of the target location. Subsequent in vitro tests of stent prototypes showed satisfying properties concerning crimpability, expansion behavior and elastic recoil to demonstrate general feasibility. Further developments and additional testing will advance the implementation of a new treatment option of ETD.
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