Development of a biodegradable microstent for minimally invasive treatment of Fallopian tube occlusions

Obstructions of the Fallopian tube represent one of the most common reasons for an unfulfilled desire to have children. Microstent technology opens up new therapeutic possibilities to restore the natural lumen of the Fallopian tube within a single treatment. Within the current work we developed a self-expandable biodegradable microstent for gynecological applications. Based on a novel microstent design, prototypes were manufactured from poly-L-lactide tubing by means of fs-laser cutting. Microstent prototypes were characterized morphologically by means of scanning electron microscopy and biaxial laser scanning. As manufactured, a microstents outside diameter of about 2.3 mm and a strut thickness/width of about 114 µm/103 µm was measured. Mechanical characterization of microstents included bending as well as crimping and release behavior. After crimping to a minimum diameter of 0.8 mm and consecutive release, a microstent recovery to a diameter of 1.8 mm was found. Therefore, proof-of-concept for the self-expandable microstent could be successfully provided. © 2020 by Walter de Gruyter Berlin/Boston 2020

Siegen Symposium for Geomeasurement Technology - Current and future challenges : from the four-eyes principle to AI

Die klimabedingt zu erwartende Zunahme von Extremwetterereignissen stellt die bebaute Umwelt vor erhebliche Herausforderungen und erfordert die Entwicklung geeigneter Anpassungsstrategien. Der Geomesstechnik kommt dabei eine besondere Bedeutung zu, denn verknüpft mit der mathematisch-mechanischen Modellbildung liefert sie die Grundlage für die Bewertung möglicher geomechanischer Risiken und für die daraus abzuleitenden Planungsmaßnahmen. In diesem Symposium werden die aktuellen Entwicklungen, die Möglichkeiten und Grenzen der Geomesstechnik in einem interdisziplinären und thematisch breit angelegten Kontext ausgelotet.The expected increase in extreme weather events due to climate change poses considerable challenges to the built environment and requires the development of suitable adaptation strategies. Geomeasurement technology is of particular importance in this context, because linked with mathematical-mechanical modeling it provides the basis for the assessment of possible geomechanical risks and for the planning measures to be derived from them. In this symposium, the current developments, the possibilities and limits of geomeasurement technology will be explored in an interdisciplinary and thematically broad context

Method for the improvement of mechanical properties of biodegradable polymeric scaffolds

At present, a main focus in the field of stent technologies is on the development of biodegradable polymeric stents. Due to inferior material characteristics of polymers compared to permanent metals stents require thicker stents struts to accomplish adequate mechanical properties. Therefore, a thermo-mechanical treatment of polymeric stents was tested, which showed a positive effect on mechanical stent characteristics

Conversion of engineering stresses to Cauchy stresses in tensile and compression tests of thermoplastic polymers

Thermoplastic polymers exhibit non-isochoric behaviour during tensile and compression testing as well as particular deformations like local necking (tension) or buckling (compression). A method for the determination of Cauchy stresses from tensile and compression tests is presented, that considers the actual deformations of the test specimens. The exact geometry of the specimens in the respective present configuration is determined in photographs, which are taken continuously throughout the test. The engineering stresses at several time points are converted into Cauchy stresses using newly developed formulas in consideration of the actual specimen geometry. For validation finite element analyses of the tensile and compression tests are performed using the identified stress-strain curves. The numerical results show good agreement with the experiments for the tested polymers. Thus a method for conversion of engineering to Cauchy stresses in tensile and compression tests could be established considering the non-isochoric deformation in plasticity. With this method “true” stress-strain curves as input for finite element material models can be identified for arbitrary materials

Investigating dynamic-mechanical properties of multi-layered materials for biomedical applications

The development and advancement of polymeric implant materials is a frequent focus in current research. The combination of polymeric materials with diverging properties provides a wide range of new materials with innovative characteristics. One technology for combining materials is to apply a coated layer onto a base material. In this work, a hyperelastic, synthetic base material was combined with a rigid biopolymer coating layer. A multilayered material with combined characteristics of both was built. In the field of processed polymers, the analysis of coating adhesion is not feasible using established methods. Therefore, a dynamic-mechanical method was investigated, which supplements the uniaxial tensile test and provides knowledge regarding mechanical resistance of the multilayered polymer structure. Furthermore, the method gets validated by SEM-imaging and evaluation of coating composition before and after testing under dynamic conditions

Investigation of Bauschinger effect in thermo-plastic polymers for biodegradable stents

The Bauschinger effect is a phenomenon metals show as a result of plastic deformation. After a primary plastic deformation the yield strength in the opposite loading direction decreases. The aim of this study is to investigate if there is a phenomenon similar to Bauschinger effect in thermoplastic polymers for stent application that would influence the mechanical properties of these biodegradable implants. Combined uniaxial tensile with subsequent compression tests as well as conventional compression tests without prior tensile loading were performed using biodegradable polymers for stent application (PLLA and a PLLA based blend). Comparing the results of compression tests with prior tensile loading to the compression-only tests a decrease in compressive strength can be observed for both of the tested materials. The conclusion of the performed experiments is that there is a phenomenon similar to Bauschinger effect not only in metallic materials but also in the examined thermoplastic polymers. The observed reduction of compressive strength as a consequence of prior tensile loading can influence the mechanical behaviour, e.g. the radial strength, of polymeric stents after sustaining a complex load history due to crimping and expansion

Investigation of Bauschinger effect in thermo-plastic polymers for biodegradable stents

The Bauschinger effect is a phenomenon metals show as a result of plastic deformation. After a primary plastic deformation the yield strength in the opposite loading direction decreases. The aim of this study is to investigate if there is a phenomenon similar to Bauschinger effect in thermoplastic polymers for stent application that would influence the mechanical properties of these biodegradable implants. Combined uniaxial tensile with subsequent compression tests as well as conventional compression tests without prior tensile loading were performed using biodegradable polymers for stent application (PLLA and a PLLA based blend). Comparing the results of compression tests with prior tensile loading to the compression-only tests a decrease in compressive strength can be observed for both of the tested materials. The conclusion of the performed experiments is that there is a phenomenon similar to Bauschinger effect not only in metallic materials but also in the examined thermoplastic polymers. The observed reduction of compressive strength as a consequence of prior tensile loading can influence the mechanical behaviour, e.g. the radial strength, of polymeric stents after sustaining a complex load history due to crimping and expansion

Optimization of manufacturing processes for biodegradable polymeric stents regarding improved mechanical properties

Although current drug eluting stents show low risks of in-stent restenosis and stent thrombosis, the presence of a permanent foreign body inside the vessel represents a major limitation. In order to overcome this limitation, stents made of biodegradable polymeric materials are currently being developed. The present work describes an optimized fabrication process for tubular semi-finished products for manufacturing of stents made of poly-L-lactide (PLLA). The impact of the haul-off speed as a major parameter during extrusion processing on the cross-sectional area of tubular specimens was analyzed. It could be shown that the crosssection of the extrudate, in particular the tubing diameter and wall thickness, can be adjusted by varying haul-off speed. In a subsequent blow molding process the influence of the holding time on polymer cold crystallization was analyzed. Thermal properties of the polymeric material after processing were examined by differential scanning calorimetry (DSC). The results showed that there is almost no cold crystallization using a holding time of at least 20 minutes. The investigations showed that semi-finished products with variable geometry and improved mechanical properties can be produced with the described extrusion and blow molding process

Investigation of balloon dilation devices for treatment of Eustachian tube dysfunction

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

Balloon-based measuring system for compliance investigations

For the development of new stent designs, the compliance of the surrounding biological tissue has to be considered. We expect to obtain parameters for simulation, stent dimensioning, and the forces acting on the stent after implantation. Starting point of the investigations is the commercially available Metricath system allowing cross-sectional lumen area measurements of arteries. Its working principle is based on the pressure-volume relationship using a balloon catheter, which is inflated to a specific pressure of about 250 mmHg and conforms to the shape and size of the lumen. However, for compliance charts multiple pressure levels and a larger pressure range are needed. To overcome this technical limitation, the Metricath balloon catheter is combined with a new inflation device, called pV-Monitor. The presented cross-sectional lumen area measurements in rigid tubes and compliance investigations of elastic tubes demonstrate the feasibility of the pV-Monitor system