Development of biodegradable stents for the treatment of Eustachian tube dysfunction

Schumann, K; Wilfling, T; Paasche, Gerrit; Salais, Robert; Lenarz, Thomas; Schmidt, W. J.; Grabow, Niels; Müller, Heinz; Momma, C.; Schmitz, Klaus‐Peter

doi:10.1515/cdbme-2018-0121

Cited by 2 publications

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“…Apart from the cardiovascular system, stents are being researched in ophthalmologic (glaucoma drainage) [4,5], otorhinolaryngologic (Eustachian tube, treatment of chronic otitis media) [6], as well as gynecologic (Fallopian tube), see Figure 2, and gastroenterologic (pancreas) application. The latter being applied in the context of endoscopic pancreatic necrosectomy [7], see Figure 3.…”

Section: Current and Future Workmentioning

confidence: 99%

Medical device innovations for cardiovascular, ophthalmologic and otolaryngologic applications

Grabow

Senz

Schmitz

2019

Current Directions in Biomedical Engineering

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The consortium RESPONSE is a cooperation between partners from science and industry within the BMBF-Program “Twenty20 - Partnership for Innovation”, 2014-2021. RESPONSE gives its partners opportunities to put medical device innovations into practice more efficiently. In order to accelerate innovation processes, joint efforts are being made along the entire translation chain. RESPONSE is focusing on the development of novel concepts of implantable medical devices for cardiovascular, ophthalmologic and ENT application. Platform technology approaches are being used to extend the range of device applications. See also: www.response.uni-rostock.de

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Section: Current and Future Workmentioning

confidence: 99%

Medical device innovations for cardiovascular, ophthalmologic and otolaryngologic applications

Grabow

Senz

Schmitz

2019

Current Directions in Biomedical Engineering

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First in vivo test of a biodegradable polymeric stent for the Eustachian tube in sheep

Winkelmann,

Lebahn,

Ezzat

et al. 2024

Front. Audiol. Otol.

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IntroductionEustachian tube dysfunction can cause inadequate ventilation of the middle ear and is therefore one of the main reasons for the development of chronic middle ear infections. This can significantly impact the quality of life. There is a variety of treatment options, but in most cases long-term success is limited. For this reason, stenting the Eustachian tube (ET) may be a safe and effective alternative. Biodegradable stents have been developed that support the impaired ET function until natural ventilation of the middle ear via the ET is restored, and dissolve after their function has been fulfilled.ObjectiveThe purpose of the current study was to investigate feasibility of implantation and degradation kinetics of biodegradable polymer stents in the ET.Study designThe study was set up as an orientation study.MethodsBiodegradable stents (diameter: 3.5 mm; length: 15 mm) were made from Poly-L-lactic acid (PLLA) in a dip-coating process and subsequent laser cutting and were crimped on a balloon catheter. Stent implantation into the ET was performed unilaterally in nine healthy female blackface sheep under endoscopic control with a dedicated insertion tool and an inflation pressure of 10 bar for 2 min. Ventilation of the middle ear was controlled by tympanometry weekly throughout the observation period of 3, 6, or 12 months (three animals each). After the final examination, cone beam computed tomography scans and histological examinations of the ETs were performed.ResultsAll stents could be inserted as planned. Pharyngeal orifices of all sheep were closed at half-time and final follow-up inspections. After 3 months, all stents were functional, but already showed first fragment formation. Six months after insertion, the stents had largely collapsed but still held open a residual lumen and after 12 months, the ETs were completely collapsed close to their natural shape. Fragments of various sizes were found distributed in the tissue beneath an epithelialized ET.ConclusionThe polymeric ET stent can be reliably positioned without generating a patulous ET. It seems to support ET function for about 3 months before functionality is lost.

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Development of biodegradable stents for the treatment of Eustachian tube dysfunction

Cited by 2 publications

References 0 publications

Medical device innovations for cardiovascular, ophthalmologic and otolaryngologic applications

Medical device innovations for cardiovascular, ophthalmologic and otolaryngologic applications

First in vivo test of a biodegradable polymeric stent for the Eustachian tube in sheep

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