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- peer-reviewed (14)
Early motion therapy plays an important role for effective long-term healing of joint injuries. In many cases, conventional dynamic orthoses fail to address the intricate movement possibilities of the underlying joints, limited by their simplistic joint representations, often represented by revolute joints, enabling rotations by only one axis. In this paper, a two-dimensional compliant tensegrity joint for use in biomedical applications is investigated. It consists of two compressed members and five compliant tensioned members. Relative movement possibilities are realized by the intrinsic compliance of the structure. In the development of these systems, the first step is the determination of the static stable equilibrium. This analysis is conducted in this paper by considering the potential energy approach or by using the geometric nonlinear finite element method. The mechanical behavior of the structure is assessed with a specific emphasis on its mechanical compliance. The primary objective of this study is the investigation of the influence of structural parameters on the overall stiffness and movability of the structure. The results underscore the significant effect of member parameters on the stiffness and movability of the compliant tensegrity joint, particularly under varying load magnitudes. These findings provide insights for optimizing the joint’s performance, contributing to its potential application in advanced orthotic and exoskeleton devices.
Following a ban on many materials containing bisphenol-A, new bisphenol-free Boron silicates have been found as substitutes. The purpose of this study is to describe the mechanical properties of these bisphenol-free magnetoactive borosilicate polymers containing hard magnetic particles. Samples of 0%, 33% and 66% by wt. were loaded for compression using a universal testing machine. The maximum forces occurring for different travel speeds were compared before and after post-magnetization treatments. The post-magnetization included 2 stages. In addition, the change in mechanical properties within 24 hours after the post-magnetization process was investigated. Furthermore, the influence of speed and particle content were investigated. In general, there is a correlation between the required compressive force and, the level of post-magnetization stress, the increase in travel speed and particle content in the boron silicate. Comparison of the non-post-magnetized and post-magnetized samples using two-tailed t-tests shows that the p-values for all weight fraction changes in NdPrFeB particles and travel speeds are less than 0.001. Also, a comparison between tests in which the traverse speed was varied also showed significant changes in the resulting compression forces. The same is valid for changes in the weight ratio of the NdPrFeB particles in the samples. For post-magnetized samples, no significant difference can be observed in the first 24 hours following magnetization. In summary, the material presents viscoelastic, plastic force-displacement behavior, which can be well recognized by its bi-linear curve shape.
The investigation shows that borosilicate polymers based on NdPrFeB can have their mechanical behavior modified and controlled by post-magnetization processes. This opens new possibilities for many future applications.
Titanium is used in many areas due to its excellent mechanical, biological and corrosion-resistant properties. Implants often have thin and filigree structures, providing an ideal application for fine cutting with laser. In the literature, the main focus is primarily on investigating and optimizing the parameters for titanium sheets with thicknesses greater than 1 mm. Hence, in this study, the basic manufacturing parameters of laser power, cutting speed and laser pulse of a 200 W modulated fiber laser are investigated for 0.15 mm thick grade 2 titanium sheets. A reproducible, continuous cut could be achieved using 90 W laser-power and 2 mm/s cutting-speed. Pulse pause variations between 85 and 335 μs in 50 μs steps and a fixed pulse width of 50 μs show that a minimum kerf width of 23.4 μm, as well as a minimum cut edge roughness Rz of 3.59 μm, is achieved at the lowest pulse pause duration. An increase in roughness towards the laser exit side, independent of the laser pulse pause duration, was found and discussed. The results provide initial process parameters for cutting thin titanium sheets and thus provide the basis for further investigations, such as the influence of cutting gas pressure and composition on the cut edge.
Titanium is used in many areas due to its excellent mechanical, biological and corrosion-resistant properties. Implants often have thin and filigree structures, providing an ideal application for laser fine cutting. In literature, the main focus is primarily on investigating and optimizing the parameters for titanium sheet thicknesses greater than 1 mm. Hence, in this study, the basic manufacturing parameters of laser power, cutting speed and laser pulsing of a 200 W modulated fibre laser are investigated for 0.15 mm thick titanium grade 2 sheets. A reproducible, continuous cut could be achieved using 90 W laserpower and 2 cutting-speed. Pulse pause variations between 85–335 μs in 50 μs steps and fixed
pulse duration of 50 μs show that a minimum kerf width of 23.4 μm, as well as a minimum cut edge roughness Rz of 3.59 μm, is achieved at the lowest pulse pause. An increase in roughness towards the laser exit side, independent of the laser pulse pause, was found and discussed. The results provide initial process parameters for cutting thin titanium sheets and thus provide the basis for further investigations, such as the influence of cutting gas pressure and composition on the cut edge.
Introduction:
Neointimal hyperplasia after percutaneous coronary intervention remains a major determinant of in-stent restenosis (ISR). The extent of mechanical vessel injury correlates with ISR. A new ex vivo porcine stent model was introduced and evaluated comparing different stent designs.
Methods:
Coronary arteries were prepared from pig hearts from the slaughterhouse and used for ex vivo implantations of coronary stents. One basic stent design in two configurations (dogbone, DB; non-dogbone, NDB) was used. Vascular injury was determined according to a modified injury score (IS).
Results:
Standardized experimental conditions ensured comparable vessel dimensions and overstretch data. DB stents caused more severe IS compared to NDB stents. The mean IS and the IS at the distal end of all stents were significantly reduced for NDB stents (ISMean, DB, 1.16 ±0.12; NDB, 1.02 ±0.12; p=0.018; ISDist, DB, 1.39 ±0.28; NDB, 1.13 ±0.24; p=0.03).
Discussion/Conclusion:
The introduced ex-vivo model allowed the evaluation of different stent designs exclude unfavorable stent designs.
Autologous lipotransfer is a promising method for tissue regeneration, because white adipose tissue contains a heterogeneous cell population, including mesenchymal stem cells, endothelial cells, immune cells, and adipocytes. In order to improve the outcome, adipose tissue can be processed before application. In this study, we investigated changes caused by mechanical processing.
Lipoaspirates were processed using sedimentation, first-time centrifugation, shear-force homogenization, and second-time centrifugation. The average adipocyte size, stromal vascular cell count, and adipocyte depot size were examined histologically at every processing step. In addition, the adipose derived stem cells (ADSCs) were isolated and differentiated osteogenically and adipogenically. While homogenization causes a disruption of adipocyte depots, the shape of the remaining adipocytes is not changed. On average, these adipocytes are smaller than the depot adipocytes, they are surrounded by the ECM, and therefore mechanically more stable. The volume loss of adipocyte depots leads to a significant enrichment of stromal vascular cells such as ADSCs. However, the mechanical processing does not change the potential of the ADSCs to differentiate adipogenically or steogenically. It thus appears that mechanically processed lipoaspirates are promising for the reparation of even mechanically stressed tissue as that found in nasolabial folds. The changes resulting from the processing correspond more to a filtration of mechanically less stable components than to a manipulation of the tissue.
Objective
The risk of in-stent restenosis can be considerably reduced by stents eluting cytostatic compounds. We created a novel drug-eluting stent system that includes several new features in the rapidly evolving field of stent-based drug delivery.
Methods and Results
The aim of the present study was the preclinical evaluation of a stent-coating system permitting individual, on-site coating of stents with a unique microporous surface allowing for individualizable, dose-adjustable, and multiple coatings with identical or various compounds, designated ISAR (individualizable drug-eluting stent system to abrogate restenosis). Stents were coated with 0.75% rapamycin solution, and high-performance liquid chromatography (HPLC)-based determination of drug release profile indicated drug release for >21 days. Rapamycin-eluting microporous (REMP) stents implanted in porcine coronary arteries were safe. To determine the efficacy of REMP stents, this novel drug-eluting stent platform was compared with the standard sirolimus-eluting stent. At 30 days, in-stent neointima formation in porcine coronary arteries was similar in both groups, yielding a significant decrease of neointimal area and injury-dependent neointimal thickness compared with bare-metal stents.
Conclusion
The ISAR drug-eluting stent platform as a novel concept for stent coating allows for a safe, effective, on-site stent coating process, thus justifying further clinical evaluation to decrease in-stent restenosis in humans.
In-stent neointima formation can be successfully attenuated by drug-eluting stents. We introduce a novel conceptual approach for stent-coating that allows for dose-adjustable, on-site stent coating process if desired with multiple compounds. Microporous stents coated with rapamycin proved safe and effective for the limitation of neointima formation in a porcine coronary stent model.
Aims
Drug-eluting stents (DES) represent a major advance in interventional cardiology. Along with the success shown, current DES also present limitations related to the presence of polymer-coating, fixed drug, and dose used. With the ISAR (Individualized Drug-Eluting Stent System to Abrogate Restenosis) project, a DES system has been developed that permits individualized choice of the drug and dose to use for the given patient. The objective of this prospective dose finding study was to assess the feasibility, safety, and efficacy of a polymer-free on-site stent coating with increasing rapamycin doses.
Methods and results
In this dose finding study, 602 patients were sequentially enrolled in four groups: microporous bare metal stent (BMS), DES stents coated with a 0.5, 1.0, and 2.0% rapamycin solution. The angiographic in-segment restenosis rate at follow-up angiography was the primary study endpoint. In-segment restenosis was significantly reduced from 25.9% with BMS to 18.9, 17.2, and 14.7% with 0.5, 1.0, and 2.0% rapamycin-eluting stents, respectively (P=0.024). Similarly, the need for target lesion revascularization at 1 year follow-up was reduced from 21.5% with BMS to 16.4, 12.6, and 8.8% with 0.5, 1.0, and 2.0% rapamycin-eluting stents, respectively (P=0.006).
Conclusion
The placement of polymer-free stents coated on-site with rapamycin is feasible and safe. Furthermore, a dose-dependent efficacy in restenosis prevention is achievable with this new DES concept.
Vascular damage develops with diverging severity during and after percutaneous coronary intervention with stent placement and is the prevailing stimulus for in-stent restenosis. Previous work has failed to link mechanical data obtained in a realistic in vivo or in vitro environment with data collected during imaging processes. We investigated whether specimens of porcine right coronary arteries soften when indented with a stent strut shaped structure, and if the softening results from damage mechanisms inside the fibrillar collagen structure. To simulate the multiaxial loading scenario of a stented coronary artery, we developed the testing device ‘LAESIO’ that can measure differences in the stress-stretch behavior of the arterial wall before and after the indentation of a strut-like stamp. The testing protocol was optimized according to preliminary experiments, more specifically equilibrium and relaxation tests. After chemical fixation of the specimens and subsequent tissue clearing, we performed three-dimensional surface and second-harmonic generation scans on the deformed specimens. We analyzed and correlated the mechanical response with structural parameters of high-affected tissue located next to the stamp indentation and low-affected tissue beyond the injured area. The results reveal that damage mechanisms, like tissue compression as well as softening, fiber dispersion, and the lesion extent, are direction-dependent, and the severity of them is linked to the strut orientation, indentation pressure, and position. The findings highlight the need for further investigations by applying the proposed methods to human coronary arteries. Additional data and insights might help to incorporate the observed damage mechanisms into material models for finite element analyses to perform more accurate simulations of stent-implantations.
Experimental and mathematical characterization of coronary polyamide-12 balloon catheter membranes
(2020)
The experimental quantification and modeling of the multiaxial mechanical response of polymer membranes of coronary balloon catheters have not yet been carried out. Due to the lack of insights, it is not shown whether isotropic material models can describe the material response of balloon catheter membranes expanded with nominal or higher, supra-nominal pressures. Therefore, for the first time, specimens of commercial polyamide-12 balloon catheters membranes were investigated during uniaxial and biaxial loading scenarios. Furthermore, the influence of kinematic effects on the material response was observed by comparing results from quasi-static and dynamic biaxial extension tests. Novel clamping techniques are described, which allow to test even tiny specimens taken from the balloon membranes. The results of this study reveal the semi-compliant, nonlinear, and viscoelastic character of polyamide-12 balloon catheter membranes. Above nominal pressure, the membranes show a pronounced anisotropic mechanical behavior with a stiffer response in the circumferential direction. The anisotropic feature intensifies with an increasing strain-rate. A modified polynomial model was applied to represent the realistic mechanical response of the balloon catheter membranes during dynamic biaxial extension tests. This study also includes a compact set of constitutive model parameters for the use of the proposed model in future finite element analyses to perform more accurate simulations of expanding balloon catheters.