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

Beiträge zur Entwicklung von Aortenklappenprothesen: Analyse des thrombogenen Potentials anhand strömungsmechanischer Untersuchungen

Die Dissertation befasst sich mit den Entwicklung eines Modells zur Bewertung des Thromboserisikos von Aortenklappenprothesen aus ingenieurwissenschaftlicher Sicht. Ziel war es, anhand dieses Modells Designaspekte und Implantationsstrategien abzuleiten, die zu einer Reduktion des Thromboserisikos von Aortenklappenprothesen führen und somit die Sicherheit und Effektivität der Implantate verbessern

Comparison of stented bifurcation and straight vessel 3D-simulation with a prior simulated velocity profile inlet

Coronary diseases are the main reason for death in the western world. Bio-fluid mechanical correlations with arterial diseases are in the focus of our research. To treat occluded vessels, stents are implanted. Stent implantations can be associated with blood flow disruptions leading to restenosis or thrombosis formation. Numerical flow simulation is a promising tool to evaluate the hemodynamic performance of cardiovascular implants, but is resource-intensive in time and computational power. Therefore, a reduction in grid size would be beneficial due to economic exploitation of computational cost. The purpose of this numerical investigation is to substitute the computational domain of a distal stented bifurcation with a stented straight vessel by using the right inlet condition. The deviation of the results of the two different methods to simulate the blood flow situation in a bifurcation is marginal. This inlet can be used for standardised simulations of bifurcations were lesions commonly occur

Augmentation of experimentally obtained flow fields by means of Physics Informed Neural Networks (PINN) demonstrated on aneurysm flow

Biofluid mechanics play an important role in the study of the mechanism of cardiovascular diseases and in the development of new implants. For the assessment of hydrodynamic parameters, experimental methods as well as in-silico approaches can be used, such as particle image velocimetry (PIV) and Deep Learning, respectively. Challenges for PIV are the optical access to the region of interest, and time consumption for measuring and post-processing analysis in particular for three dimensional flow. To overcome these limitations state-of-the-art deep learning algorithms could be utilized to augment spatially coarse resolved flow fields. In this study, we demonstrate the use of Physics Informed Neural Networks (PINN) to augment PIV measurement data. To demonstrate a combined workflow, we investigate the flow of a Newtonian fluid through a simplified aneurysm under laminar conditions. Generation of synthetic PIV particle images of a single measurement plane and the corresponding PIV vector calculations were performed as the basis for the PINN algorithm. Based on the Navier-Stokes equations the PINN reconstructs the entire 3D flow field and pressure distribution inside the aneurysm. We observed qualitative agreements between ground through data and PINN predictions. Nevertheless, there are substantial differences in the quantitative, locally resolved comparison of the flow metrics, despite the generally tendency for the PINN algorithm to correctly augment the flow field

In silico model to assess thrombosis risk of TAVR with hemodynamic predictors using fluid structure interaction

The promising results of transcatheter aortic valve replacement (TAVR) over the past two decades indicate an expansion of the patient cohort toward patients with intermediate or low surgical risk. Since some complications of TAVR have already been minimized, subclinical leaflet thrombosis (SLT) has gained importance in recent years. SLT is manifested by a thrombotic layer on the prosthetic leaflets that gradually reduces leaflet motion. The resulting decrease in functionality of the TAVR causes a need for re-intervention. The origin of SLT and approaches to prevent SLT are still unexplored. For this reason, we have developed an in silicomodel that can be used during the design development process of TAVR devices to estimate the thrombosis risk of the implant. Based on passive scalar transport, hemodynamic metrics are used to quantify platelet activation and aggregation which are associated with the formation of thrombosis. In conjunction with a numerical simulation model considering the fluid-structure interaction between the blood mimicking fluid and the TAVR implanted in an aortic root, the thrombosis risk can be modeled. The simulation model can be used to calculate the three-dimensional flow structures within the native sinus and neo-sinus and also provides the ability to derive metrics to assess the risk of thrombosis. We demonstrated that this in silicomodel is a time-effective tool to assess thrombosis risk in TAVR product development

Investigations of flow alteration of commissural misalignment of TAVR using Particle Image Velocimetry

Due to the raising number of TAVR implantations (transcatheter aortic valve replacement), tests for durability and prevention of associated diseases are becoming increasingly important. Not only the anatomy but also the positioning of the TAVR is decisive for its clinical performance. A misalignment in the circumferential direction can influence the flow in the sinus and thus inhibit the blood supply of the coronary arteries and influence the thrombosis potential. Therefore, the modification of the flow field is investigated in this study. For the characterization of the flow fields the measuring method of digital particle image velocimetry is used. A hydraulic circulation model is used to generate physiological flow and pressure conditions. Additionally, an aortic root model with Sinus Valsalvae, which represents the implantation environment, was developed. A prototype of a TAVR was implanted aligned to the commissure lines of the native valve leaflets on the one hand, and misaligned by 60 degree to the commissure of the native valves on the other hand. By determining the velocity vector fields, it could be shown that implantation of the TAVR with a commissureal misalignment influences the flow around the leaflets. A comparison of the flow fields shows that different recirculation areas occur. This is also indicated by a comparison of the mean velocities in the sinus and the observed shear rates. The influence of the altered flow field on the thrombosis and hemolysis potential should be investigated in future studies

Development of a test setup for hydrodynamic characterization of hydrocephalus shunts

Implantation of a shunt system is the most common neurosurgical procedure for the treatment of hydrocephalus. Hydrodynamic parameters of hydrocephalus shunt systems are valuable variables to address patients' needs. In this report, we present a test setup to evaluate hydrodynamic parameters of hydrocephalus shunt systems. The test setup was validated using a stainless steel capillary and compared with the analytical solution according to Bernoulli's equation. It was demonstrated that the experimental setup is able to model the pressure in a physiologically relevant range. The measured and averaged flow resistance was 2.96 mmHg/(ml min-1). According to the analytical solution of Bernoulli's equation, the flow resistance is 2.86 mmHg/(ml min-1). Therefore, the measured flow resistance is 3.5% higher than the analytical solution. Moreover, the nonlinear characteristic of the pressure drop at the inlet and outlet of the capillary plays a minor role compared to the friction of the tube flow. As a result, the increase in flow rate with increasing pressure load can be well approximated by a linear function for the low flow rates measured here. The experimental setup presented will be used in the future to characterize commercially available shunt systems under various hydrodynamic conditions

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

Inflow mapping method for numerical flow simulations of OCT-based patient-specific vessels using CFD

Alteration of the flow characteristics in coronary vessels is correlated with coronary heart disease (CHD). In particular, wall shear stress (WSS) appears to be a hemody-namic key factor in the genesis of CHD. Since computational fluid dynamics (CFD) is a well-known method for the inves-tigation of WSS, it may be a valuable tool for the prediction of CHD. Latest imaging techniques, such as optical coher-ence tomography (OCT) in conjunction with angiography deliver precise 2D data sets of patient-specific vessel geome-try, which can be used for CFD analysis. Current CFD stud-ies utilize patient-specific geometries, but are lacking well defined physiologic inflow conditions

Side-branch expansion capacity of contemporary DES platforms

Background!#!Percutaneous coronary interventions (PCI) of bifurcation stenoses are both complex and challenging. Stenting strategies share that the stents' side cells must be carefully explored and appropriately prepared using balloons or stents. So far, stent manufacturers have not provided any information regarding side-branch expansion capacity of their stent platforms.!##!Aims!#!Given that drug-eluting stent (DES) information regarding their mechanical capacity of side-branch expansion is not available, we aimed to evaluate contemporary DES (Orsiro, BIOTRONIK AG; Xience Sierra, Abbott Vascular; Resolute Integrity, Medtronic; Promus Premier Select, Boston Scientific; Supraflex Cruz, Sahajan and Medical Technologies) by their side-branch expansion behavior using in vitro bench testing.!##!Methods!#!In this in vitro study, we analyzed five commercially available DES (diameter 3.0 mm), measuring their side-branch expansion following inflation of different high-pressure non-compliant (NC) balloons (balloon diameter: 2.00-4.00 mm), thereby revealing the morphological characteristics of their side-branch expansion capacities.!##!Results!#!We demonstrated that all tested contemporary DES platforms could withstand large single-cell deformations, up to 4.0 mm. As seen in our side-branch experiments, DES designs consisting of only two connectors between strut rings did not only result in huge cell areas, but also in larger cell diameters following side-branch expansion compared with DES designs using three or more connectors. Furthermore, the stent cell diameter attained was below the balloon diameter at normal pressure.!##!Conclusions!#!We recommend that the expansion capacity of side-branches should be considered in stent selection for bifurcation interventions