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

Dynamic image analysis of transparent particles released during the simulated use test of cardiovascular devices

For product approval of coated cardiovascular devices, the assessment of particle release is essential. Particularly challenging are delivery systems equipped with hydrophilic coatings releasing highly transparent particles. The aim of this study was to compare two different methods of particle counting, namely the light obscuration method and the dynamic image analysis (DIA), with respect to optical transparent particles. The particles were collected during the simulated use of cardiovascular catheters and analysed in suspension with a dynamic imaging device (FlowCam, Fluid Imaging Technologies). Particles were detected by a greyscale threshold and imaged to analyse their shape and transparency. The statistical influence of the threshold on particle counts and size distribution was determined and compared to light obscuration particle counting (Model 9703 with sensor HRLD 400CE, HIAC ROYCO). The light obscuration method provided lower particle counts in suspensions containing a high amount of transparent particles. The lower the detection threshold, the higher the particle counts were. In conclusion, it is important to adapt the threshold value for samples that are expected to contain a high amount of transparent particles. DIA may be suggested as a valuable additional method for particulate analysis

A method to determine the kink resistance of stents and stent delivery systems according to international standards

The kink behavior of vascular stents is of particular interest for clinicians, stent manufacturers and regulatory as a kinked stent generates a lumen loss in the stented vessel and can lead to in-stent restenosis. In this study methods to determine the kink resistance of stents and stent delivery systems according to the ISO 25539-2 and FDA guidance no. 1545 were presented. The methods are applicable for balloon expandable stents as well as for self-expanding stents and determine the lumen loss and residual diameter change dependent on the specific bending radius

Acute drug transfer and particle release of drug coated balloons within a porcine in-vitro model

Drug coated balloons (DCB) are used in the therapy of coronary as well as peripheral artery disease. The success of drug transfer to the vessel wall depends on the excipient used in combination with paclitaxel as antiproliferative drug. Although in-vivo studies show very good results with this technology, there is a lack of in-vitro test methods for characterization of various DCB available on the market. This study describes a method to gain information about the drug transfer and the particle release of three different DCB based on cetylpyridinium salycate (Cetpyrsal), hyaluronic acid and iopromide within a porcine in-vitro model. The Cetpyrsal-based DCB showed promising results with the highest drug transfer while producing the lowest number of particles

Support function of self-expanding nitinol stents – Are radial resistive force and crush resistance comparable?

The main task of any vascular stent is the mechanical support of the re-opened vessel. This support function may be quantified by the compressive properties of the stent in radial outer loading conditions. Different test methods are standardized and are accepted to provide relevant data. Six commercially available self-expanding stents were investigated with regard to their forcedeformation behavior during radial as well as elliptical deformation. The measured radial resistive force and crush resistance were not qualitatively congruent for all stents. As a conclusion both test methods should be considered when describing the compressive properties of self-expanding stents

Optimization of online particle counting with a 3D-printed bubble trap

Particulate evaluation is needed for the approval of cardiovascular devices. Air bubbles lead to higher particle counts when light obscuration method (LOM) is used. The aim of the study was to test a custom made bubble trap that removes air bubbles (2 - 100 μm) from a flow circuit prior to online particle counting. Artificially generated air bubbles were counted with an online particle counter with and without the bubble trap. Air bubbles were reduced by about 71 % to 91 % by using the bubble trap

Test methods for evaluation of balloon expandable vascular stents – measurement of radial strength and stiffness

The radial strength of balloon expandable stents represents a key property for a successful recanalization of sclerotic blood vessels. This study focuses on the most commonly used method for investigation of radial strength and radial stiffness via segmented head test setup. A custom made user software was used for evaluation of the radial force curves considering requirements of international standards such as ASTM F3067. Contributing factors during measurement such as friction and test setup deformation as well as the single cycle and multi cycle approach were addressed and discussed

Cyclic stress-strain behavior of polymeric nonwoven structures for the use as artificial leaflet material for transcatheter heart valve prostheses

Xenogenic leaflet material, bovine and porcine pericardium, is widely used for the fabrication of surgically implanted and transcatheter heart valve prostheses. As a biological material, long term durability of pericardium is limited due to calcification, degeneration and homogeneity. Therefore, polymeric materials represent a promising approach for a next generation of artificial heart valve leaflets with improved durability. Within the current study we analyzed the mechanical performance of polymeric structures based on elastomeric materials. Polymeric cast films were prepared and nonwovens were manufactured in an electrospinning process. Analysis of cyclic stress-strain behavior was performed, using a universal testing machine. The uniaxial cyclic tensile experiments of the elastomeric samples yielded a non-linear elastic response due to viscoelastic behavior with hysteresis. Equilibrium of stress-strain curves was found after a specific number of cycles, for cast films and nonwovens, respectively. In conclusion, preconditioning was found obligatory for the evaluation of the mechanical performance of polymeric materials for the use as artificial leaflet material for heart valve prostheses

Direct comparison of coronary bare metal vs. drug-eluting stents: same platform, different mechanics?

Abstract Background Drug-eluting stents (DES) compared to bare metal stents (BMS) have shown superior clinical performance, but are considered less suitable in complex cases. Most studies do not distinguish between DES and BMS with respect to their mechanical performance. The objective was to obtain mechanical parameters for direct comparison of BMS and DES. Methods In vitro bench tests evaluated crimped stent profiles, crossability in stenosis models, elastic recoil, bending stiffness (crimped and expanded), and scaffolding properties. The study included five pairs of BMS and DES each with the same stent platforms (all n = 5; PRO-Kinetic Energy, Orsiro: BIOTRONIK AG, Bülach, Switzerland; MULTI-LINK 8, XIENCE Xpedition: Abbott Vascular, Temecula, CA; REBEL Monorail, Promus PREMIER, Boston Scientific, Marlborough, MA; Integrity, Resolute Integrity, Medtronic, Minneapolis, MN; Kaname, Ultimaster: Terumo Corporation, Tokyo, Japan). Statistical analysis used pooled variance t tests for pairwise comparison of BMS with DES. Results Crimped profiles in BMS groups ranged from 0.97 ± 0.01 mm (PRO-Kinetic Energy) to 1.13 ± 0.01 mm (Kaname) and in DES groups from 1.02 ± 0.01 mm (Orsiro) to 1.13 ± 0.01 mm (Ultimaster). Crossability was best for low profile stent systems. Elastic recoil ranged from 4.07 ± 0.22% (Orsiro) to 5.87 ± 0.54% (REBEL Monorail) including both BMS and DES. The bending stiffness of crimped and expanded stents showed no systematic differences between BMS and DES neither did the scaffolding. Conclusions Based on in vitro measurements BMS appear superior to DES in some aspects of mechanical performance, yet the differences are small and not class uniform. The data provide assistance in selecting the optimal system for treatment and assessment of new generations of bioresorbable scaffolds. Trial registration: not applicabl