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In recent decades, biofilm-associated infections have become a major problem in many medical fields, leading to a high burden on patients and enormous costs for the healthcare system. Microbial infestations are caused by opportunistic pathogens which often enter the incision already during implantation. In the subsequently formed biofilm bacteria are protected from the hosts immune system and antibiotic action. Therefore, the development of modified, anti-microbial implant materials displays an indispensable task. Thermoplastic polyurethane (TPU) represents the state-of-the-art material in implant manufacturing. Due to the constantly growing areas of application and the associated necessary adjustments, the optimization of these materials is essential. In the present study, modified liquid silicone rubber (LSR) surfaces were compared with two of the most commonly used TPUs in terms of bacterial colonization and biofilm formation. The tests were conducted with the clinically relevant bacterial strains Staphylococcus aureus and Staphylococcus epidermidis. Crystal violet staining and scanning electron microscopy showed reduced adhesion of bacteria and thus biofilm formation on these new materials, suggesting that the investigated materials are promising candidates for implant manufacturing.

Local drug delivery has become indispensable in biomedical engineering with stents being ideal carrier platforms. While local drug release is superior to systemic administration in many fields, the incorporation of drugs into polymers may influence the physico-chemical properties of said matrix. This is of particular relevance as minimally invasive implantation is frequently accompanied by mechanical stresses on the implant and coating. Thus, drug incorporation into polymers may result in a susceptibility to potentially life-threatening implant failure. We investigated spray-coated poly-l-lactide (PLLA)/drug blends using thermal measurements (DSC) and tensile tests to determine the influence of selected drugs, namely sirolimus, paclitaxel, dexamethasone, and cyclosporine A, on the physico-chemical properties of the polymer. For all drugs and PLLA/drug ratios, an increase in tensile strength was observed. As for sirolimus and dexamethasone, PLLA/drug mixed phase systems were identified by shifted drug melting peaks at 200 &deg, C and 240 &deg, C, respectively, whereas paclitaxel and dexamethasone led to cold crystallization. Cyclosporine A did not affect matrix thermal properties. Altogether, our data provide a contribution towards an understanding of the complex interaction between PLLA and different drugs. Our results hold implications regarding the necessity of target-oriented thermal treatment to ensure the shelf life and performance of stent coatings.

Additive manufacturing (AM) of drug delivery systems (DDS) is a promising tool for the development of patient-tailored treatments to ensure exact formation of individual scaffolds with specific incorporated drug combinations and concentrations. This study describes a novel hybrid AM process, combining stereolithography and inkjet printing, for printing a basic Polyethylene Glycol Diacrylate (PEGDA) DDS body and placing the model drug acetylsalicylic acid (ASA) in different drug depot locations. Adjusting the drug release by drug depot positioning according to drug diffusion is being investigated. The drug release rates from first 3D printed samples are being shown., Transactions on Additive Manufacturing Meets Medicine, Vol 2 No 1 (2020): Trans. AMMM

Polymers are commonly used in medical device manufacturing, e.g. for drug delivery systems, bone substitutes and stent coatings. Especially hydrogels exhibit very promising properties in this field. Hence, the development of new hydrogel systems for customized application is of great interest, especially regarding the swelling behavior and mechanical properties as well as the biocompatibility. The aim of this work was the preparation and investigation of various polyelectrolyte and poly-ionic liquid based hydrogels accessible by radical polymerization. The obtained polymers were covalently crosslinked with N,N'-methylenebisacrylamide (MBAA) or different lengths of poly(ethyleneglycol)diacrylate (PEGDA). The effect of different crosslinker-to-monomer ratios has been examined. In addition to the compression curves and the maximum degree of swelling, the biocompatibility with L929 mouse fibroblasts of these materials was determined in direct cell seeding experiments and the outcome for the different hydrogels was compared.

Electrospinning is a method for producing fibrous polymer scaffolds that can be applied in drug delivery systems as well as for polymer-based implants. Biodegradable polymers for the purpose of cardiac tissue engineering are often applied as fibrous scaffolds for morphological mimikry of natural matrices but also drugeluting approaches are very promising. Hydrolytic degradation is one of the key parameters for successful application. The focus of our investigations is on monitoring accelerated in vitro degradation of electrospun nonwoven scaffolds. In the presented study degradation of poly(Llactide) is accelerated by alkaline hydrolysis. The process is characterized by weight loss, loss of molecular mass, surface morphology and thermal behavior of nonwoven samples, showing a fast degradation of the fibrous material within two weeks.

The analysis of device drug content typically is carried out by means of chromatographic methods such as high performance liquid chromatography (HPLC) or liquid chromatography-mass spectrometry (LCMS). These approved methods are particularly fast, cost-efficient and ubiquitous in chemical-analytical laboratories. However, these quantitative methods necessitate the drug being eluted, which represents a destructive process. A novel alternative to these well-established methods [1, 2] is the Raman spectroscopy, which is fast and cost-efficient, as well [3]. Additionally, it offers the advantage of nondestructive analysis without the need for a special sample preparation. Within the current investigation we applied Raman spectroscopy for the qualitative and quantitative analysis of dexamethasone (DMS), a glucocorticoid, incorporated in a silicone matrix. The investigation was conducted in a rectangular area on the sample surface. The required number of measuring points (spectra) was determined. Calibration was performed with samples containing different amounts of DMS. The evaluation of Raman spectra is based on the analysis of the peak areas of the bands at 795 rel. cm-1(silicone) and 1,663 rel. cm-1(DMS). Remarkably, next to a precise overview of DMS distribution, an exact and reproducible quantification of incorporated DMS could be obtained.

The implantation of transcatheter aortic valve prostheses (TAVP) for therapy of aortic valve stenosis shows more and more clinically non-inferiority results compared to surgical valve replacement in intermediate and low risk patients. Commonly clinically used TAVP are manufactured from chemically fixed xenograft leaflet material, e.g. bovine or porcine pericardium. While the clinical use of TAVP currently extends, challenges concerning valve durability and leaflet calcification have to be addressed. In this regard, artificial leaflet materials represent a promising option for a next generation of TAVP. As a first step for the development of TAVP from polymeric nonwoven, the aim of this study was to determine the influence of leaflet geometry on hydrodynamic performance of TAVP prototypes. Based on a parametric model of the valve leaflets, we varied the curvature of the belly line forming the leaflet coaptation area from an initial, quite concave, leaflet geometry with a value of 0.5° to an almost straight geometry for the leaflets with a value 0.15°. Manufacturing of TAVP prototypes was conducted by means of electrospinning technique with a polycarbonate based silicone elastomer. Hydrodynamic characterization according to ISO 5840-3 standards was performed using a pulse duplicator system with a heart rate of 70 BPM, systolic duration of 35%, mean aortic pressure of 100 mmHg and a stroke volume of 96 ml. Cardiac output as well as mean transaortic pressure gradient, closing volume, leakage volume and regurgitation were measured to compare the different leaflet geometries. To summarize, the curvature of the leaflets’ belly has a crucial impact on TAVP hydrodynamics under physiological test conditions. In particular, the opening and closing behavior is strongly influenced by a steeper curvature leading to larger closing volumes and higher regurgitant fractions. Further studies are planned to identify an optimum with respect to leaflet material selection, leaflet geometry and hydrodynamic properties of TAVP.