Hybrid interpenetrating network of polyester coronary stent with tunable biodegradation and mechanical properties.

Poly(l-lactide) (PLLA) is an important candidate raw material of the next-generation biodegradable stent for percutaneous coronary intervention, yet how to make a polyester stent with sufficient mechanical strength and relatively fast biodegradation gets to be a dilemma. Herein, we put forward a hybrid interpenetrating network (H-IPN) strategy to resolve this dilemma. As such, we synthesize a multi-functional biodegradable macromer of star-like poly(d,l-lactide-co-ɛ-caprolactone) with six acrylate end groups, and photoinitiate it, after mixing with linear PLLA homopolymer, to trigger the free radical polymerization. The resultant crosslinked polymer blend is different from the classic semi-interpenetrating network, and partial chemical crosslinking occurs between the linear polymer and the macromer network. Combined with the tube blow molding and the postprocessing laser cutting, we fabricate a semi-crosslinked-polyester biodegradable coronary stent composed of H-IPN, which includes a physical network of polyester spherulites and a chemical crosslinking network of copolyester macromers and a part of homopolymers. Compared with the currently main-stream PLLA stent in research, this H-IPN stent realizes a higher and more appropriate biodegradation rate while maintaining sufficient radial strength. A series of polymer chemistry, polymer physics, polymer processing, and in vitro and in vivo biological assessments of medical devices have been made to examine the H-IPN material. The interventional implanting of the H-IPN stent into aorta abdominalis of rabbits and the follow-ups to 12 months have confirmed the safety and effectiveness.

Identification of metabolism terms significantly affecting hepatocellular carcinoma immune microenvironment and immunotherapy response.

Metabolic pathways exert a significant influence on the onset and progression of cancer. Public data on hepatocellular carcinoma (HCC) patients were obtained from The Cancer Genome Atlas (TCGA) and International Cancer Genome Consortium (ICGC) databases. Analysis was performed in R software using different R packages. Here, we integrated the data from multiple independent HCC cohorts, including TCGA-LIHC, ICGC-FR and ICGC-JP. Then, the enrichment score of 21 metabolism-related pathways was quantified using the ssGSEA algorithm. Next, univariate Cox regression analysis was applied to identify the metabolic terms with significant correlation to patient survival. Finally, a prognosis model based on linoleic acid metabolism, sphingolipid metabolism and regulation of lipolysis in adipocytes was established, which showed good performance in predicting patients' survival. Furthermore, we conducted a biological enrichment analysis to delineate the biological disparities between high- and low-risk patients. Notably, we discerned differences in the microenvironments between these two patient groups. We also found that low-risk patients could potentially respond better to immunotherapy. Drug sensitivity analysis suggested that low-risk patients are more susceptible to bexarotene and erlotinib, yet exhibit resistance to ATRA and bleomycin. Furthermore, through the use of LASSO logistic regression analysis, we identified 19 characteristic genes, which could robustly indicate the risk groups. Our research underscores the role of linoleic acid metabolism, sphingolipid metabolism and the regulation of lipolysis in adipocytes in HCC, pointing towards potential avenues for future research.

Mechanical and hydrodynamic effects of stent expansion in tapered coronary vessels.

Percutaneous coronary intervention (PCI) has become the primary treatment for patients with coronary heart disease because of its minimally invasive nature and high efficiency. Anatomical studies have shown that most coronary vessels gradually shrink, and the vessels gradually become thinner from the proximal to the distal end. In this paper, the effects of different stent expansion methods on the mechanical and hemodynamic behaviors of coronary vessels and stents were studied. To perform a structural-mechanical analysis of stent implantation, the coronary vessels with branching vessels and the coronary vessels with large bending curvature are selected. The two characteristic structures are implanted in equal diameter expansion mode and conical expansion mode, and the stress and mechanical behaviors of the coronary vessels and stents are analyzed. The results of the structural-mechanical analysis showed that the mechanical behaviors and fatigue performance of the cobalt-chromium alloy stent were good, and the different expansion modes of the stent had little effect on the fatigue performance of the stent. However, the equal diameter expansion mode increased distal coronary artery stress and the risk of vascular injury. The computational fluid dynamics analysis results showed that different stent expansion methods had varied effects on coronary vessel hemodynamics and that the wall shear stress distribution of conical stent expansion is more uniform compared with equal diameter expansion. Additionally, the vortex phenomenon is not apparent, the blood flow velocity is slightly increased, the hydrodynamic environment is more reasonable, and the risk of coronary artery injury is reduced.

Fluid-Structure Interaction Analysis on the Influence of the Aortic Valve Stent Leaflet Structure in Hemodynamics.

Transcatheter aortic valve replacement (TAVR) is a minimally invasive surgical treatment for heart valve disease. At present, personalized TAVR valves are not available for some patients. This study adopts the fluid-structure interaction (FSI) model of the research object that has a three-disc leaflet form and structural design in the valve leaflet area. The valve opening shape, orifice area, stress-strain, and distribution of hemodynamic flow and pressure were compared under the condition of equal contact area between valve and blood. The FSI method was used to simulate the complex three dimensional characteristics of the flow field more accurately around the valve after TAVR stent implantation. Three personalized stent systems were established to study the performance of the leaflet design based on computational fluid dynamics. By comparing the different leaflet geometries, the maximum stress on leaflets and stents of model B was relatively reduced, which effectively improved the reliability of the stent design. Such valve design also causes the opening area of the valve leaflet to increase and the low-velocity area of the flow field to decrease during the working process of the valve, thus reducing the possibility of thrombosis. These findings can underpin breakthroughs in product design, and provide important theoretical support and technical guidance for clinical research.

Investigation of mechanical behaviors and improved design of V-shaped braid stents.

V-shaped braid stents (VBSs), as highly retrievable and flexible nitinol stents, are extensively applied in endovascular diseases. They also cause less damage to vessel wall compared to tube-cutting stents. However, poor performance of VBS or suboptimal operation can give rise to unwanted clinical situations such as thrombosis and intimal hyperplasia. Therefore, research on designing factors affecting the performance of these devices is of great significance. Furthermore, simulation of stenting process can help designers understand the interactions of stents and vessel wall to reduce time to market. Thus, finite element analysis (FEA) and bench test are performed taking into account both designing factors and stenting process of VBS, including development of parametric modeling tool, research on the relationships among structural parameters and radial force, exploration of the interactions of VBS and vessel wall and pulsating load effect. This research was performed using a commercial solver Abaqus/standard with a user material subroutine (UMAT/nitinol). Structural parameters of VBS, unit-cell height and wire diameter have significant impacts on radial force, unit-cell number has slight influence on radial force, and arc diameter has almost negligible impact on radial force. Without pulsatile load, maximum stress and strain always occur in arc position; however, in pulsatile load, maximum stress and strain are gradually transformed to strut position. The stress created near vessel wall and VBS interface is higher than interaction stress due to pulsating load. The obtained result provided valuable information on the structural design of stents as well as the effects of stent on vessel wall and that vessel wall on stent deformation.Graphical abstract[Formula: see text].

Comparative Study of Degradation Behavior of Bioresorbable Cardiovascular Scaffolds.

This comparative study investigated the biodegradation behavior and mechanism of bioresorbable cardiovascular scaffolds using bench testing under physiological conditions and in vivo experiment. The results show that the molecular weight of the scaffold decreased with respect to time after implantation in both in vivo and in vitro tests. It was found that the molecular weights of the implanted scaffolds in the in vivo and in vitro models decreased to 61.8 and 68.5% respectively 6 months after implantation, but the thermodynamic properties of the scaffold material were not significantly affected by the 6-month degradation. Moreover, the study indicated that in spite of the 6-month degradation, the scaffold maintained sufficient radial strength and mechanical integrity. Furthermore, it was noted that the changes in the trends of the mechanical properties and degradation behavior of the scaffolds in the in vitro model were coherent with the results of the in vivo study, which means the in vitro study of the degradation behavior of polylactic acid (PLA) scaffold could offer clinical relevant data and physical insights to predict the in vivo performance.

[Related research on mechanical property of valve membrane in transcatheter bioprosthesis valve based on the chemical modification and cutting technology].

The aim of this research is to investigate the preparation method of valve membrane in transcatheter bio- prosthetic valve, and to study the effect of chemical modification and cutting technology to tensile property and suture force property of valve membrane. We carried out a series of processes to perform the tests, such as firstly to test the crosslinking degree of valve membrane using ninhydrin method, then to test the tensile property and suture force property by using Instron's biomechanicAl testing equipment, and then to observe the collagen fiber orientation in valve membrane using Instron's biomechanical testing equipment and using field emission scanning electron microscopy. The study indicated that after the chemical modification, the crosslinking degree, tensile strength and suture force strength increasing rate of valve membrane were 93.78% ± 3. 2%, (8.24 ± 0.79) MPa, 102%, respectively. The valve membrane had a better biomechanical property and would be expected to become valve membrane in transcatheter bioprosthesis valve.

Degradation model of bioabsorbable cardiovascular stents.

This study established a numerical model to investigate the degradation mechanism and behavior of bioabsorbable cardiovascular stents. In order to generate the constitutive degradation material model, the degradation characteristics were characterized with user-defined field variables. The radial strength bench test and analysis were used to verify the material model. In order to validate the numerical degradation model, in vitro bench test and in vivo implantation studies were conducted under physiological and normal conditions. The results showed that six months of degradation had not influenced the thermodynamic properties and mechanical integrity of the stent while the molecular weight of the stents implanted in the in vivo and in vitro models had decreased to 61.8% and 68.5% respectively after six month's implantation. It was also found that the degradation rate, critical locations and changes in diameter of the stents in the numerical model were in good consistency in both in vivo and in vitro studies. It implies that the numerical degradation model could provide useful physical insights and prediction of the stent degradation behavior and evaluate, to some extent, the in-vivo performance of the stent. This model could eventually be used for design and optimization of bioabsorbable stent.

[Finite element analysis for compression and expansion behavior of magnesium stent].

Magnesium stents have gained increasing interest as an ideal stent of future intervention. In order to study the deformation behavior of magnesium alloy stents in the interventional treatment, the finite element method was used to analysis the effects of different crimp and expansion dimensions on the mechanical properties (maximum stress, radial recoil rate, longitudinal shortening rate and radial strength). The results showed that crimping and expanding have a minimal influence on the stent radial strength. When the expansion size is same, the maximum equivalent stress and recoil rate decrease with the crimp size. When the crimp size is same, in contrast with the radial recoil rate, the maximum equivalent stress and longitudinal shortening rate increase with the expansion size. In addition the paper verified the radial strength-radial displacement curve obtained by FEM. Results are basically consistent, indicating the finite element method can efficiently provide researchers with reliable, high-quality design.

[Optimization based on finite element technique of nitinol stent].

The finite element method was used for simulating the mechanical performance and fatigue safety of three different structures of Nitinol stent. According to the actual situation, after proposing reasonable assumptions and simplification, the geometry model and finite element model establishment, material mode selection and boundary condition setting are completed. The strain and fatigue life of different stent edges wide (omega) or strut angle (theta) are computed. The result can provide a valuable reference for the optimal design of stent.

[Application status and prospects of thrombectomy devices for acute ischemic stroke].

The character and application status of interventional thrombectomy devices for acute ischemic stroke (AIS) are briefly introduced and the development trend is also analyzed.

Fatigue life analysis and experimental verification of coronary stent.

A computational and experimental method on biomechanics of stent is presented to analyze the stress distribution of different phases and evaluate the fatigue life according to Goodman criteria. As a result, the maximum stress and alternating stress were always located at the curvature area of rings, the fatigue bands in the experiment also verified the computation rationality. Matching between the numerical simulation and experimental results was satisfactory, which proved that the finite element analysis could provide theoretical evidence and help design and optimize the stent structure.

Treatment of distal internal carotid artery aneurysm with the willis covered stent: a prospective pilot study.

PURPOSE: To evaluate the flexibility and efficacy of the Willis covered stent in the treatment of distal internal carotid artery (DICA) aneurysms. MATERIALS AND METHODS: The study was approved by the authors' institutional review board, and the research was conducted by the authors' institution and the MicroPort Medical Company (Shanghai, China). Thirty-one patients with 33 DICA aneurysms were considered for treatment with a Willis covered stent. The angiographic assessments were categorized as complete or incomplete occlusion. The data on technical success, initial and final angiographic results, mortality, morbidity, and final clinical outcome were collected, and follow-up was performed at 1, 3, 6, and 12 months and yearly after the procedures. RESULTS: Navigation and deployment of the covered stents were successful in 97.6% (41 of 42; 95% confidence interval [CI]: 93%, 102%) of the attempted stent placement procedures. The initial angiographic results showed a complete occlusion in 23 patients with 25 aneurysms (of 32 aneurysms, 78.1% [95% CI: 63%, 93%]) and an incomplete occlusion in seven patients with seven aneurysms (21.9%). The angiographic follow-up (mean, 14 months [95% CI: 12, 15 months]) findings exhibited a complete occlusion in 27 patients with 29 aneurysms (of 31 aneurysms, 93.5% [95% CI: 84%, 103%]) and an incomplete occlusion in two aneurysms (6.5%), with a mild in-stent stenosis in two patients. The clinical follow-up (mean, 27 months [95% CI: 23, 30 months]) demonstrated that 15 patients experienced a full recovery and 14 patients improved. CONCLUSION: The preliminary results demonstrate good flexibility and efficacy of the Willis covered stent in the treatment of DICA aneurysms in selected patients; longer follow-up and expanded clinical trials are needed.

[Finite element analysis and fatigue tests for nitinol vascular stents].

This essay is to make brief comments on the Nitinol vascular stents fatigue lifetime requirements, finite element analysis and fatigue lifetime tests etc.

[Nitinol alloy's applications in cerebral interventional devices].

With the development of cerebral interventional medical devices, Nitinol alloy has been widely used in clinical fields as a good biomaterial. This essay is to make brief comments on Nitinol alloy's present development, its material characteristics, medical basic researches, and applications in cerebral interventional devices.