Search Results (54)

Vein graft restenosis remains a major complication following coronary artery bypass grafting (CABG), mainly due to the abnormal proliferation of vascular smooth muscle cells (VSMCs) and impaired endothelial repair. While external stents (eStents) can provide mechanical support and limit adverse remodeling, traditional metallic stents are non-degradable and may induce chronic inflammation and fibrosis. In contrast, many bioresorbable materials degrade too quickly or lack mechanical strength. These challenges highlight the need for external stents that combine sufficient mechanical strength with biodegradability to support long-term graft patency. This is the first study that develops a chlorogenic acid–strontium (SrCA)-loaded polycaprolactone bioresorbable eStent that inhibits VSMC proliferation and enhances endothelial repair via Hippo–Yes-associated protein (YAP) signaling, addressing vein graft restenosis post-CABG. Combining mechanical support and biodegradability, it overcomes the limitations of non-degradable stents and rapidly degrading biomaterials, elucidates the potential of natural polyphenol–metal ion complexes in vascular remodeling, and offers an innovative strategy for the prevention of vein graft restenosis. Full article

Innovations in additive manufacturing (AM) methods represent a significant advancement in manufacturing technology, opening new avenues for creating objects in various shapes and sizes. Fused deposition modeling (FDM) is a specialized AM technique in which computers build layers upon each other to form a complete 3D object. The feasibility of producing metal parts using these methods has been thoroughly analyzed, but the design process has yet to catch up with manufacturing capabilities. Biodegradable aliphatic polyester PLA is derived from lactic acid. To enhance its strength, PLA is combined with metal particles, resulting in versatile property improvements and applications. While the aesthetic and functional qualities of PLA–metal composite filaments are intriguing, they also present difficulties related to extrusion, equipment wear, and maintaining consistent print quality. These challenges could be mitigated, to some extent, with careful tuning and specialized hardware. However, the inferior mechanical properties of bioresorbable PLA filaments highlight the need for the development of infilled PLA filaments to improve strength and other characteristics. This review discusses the 3D printing of PLA infilled with metal particles, various materials used, and their properties as a matter of interest in AM technology. Additionally, the applications of PLA–metal composites, along with their implications, limitations, and prospects, are comprehensively examined in this article. This sets the stage for the development of high-strength, sustainable materials for use in a range of engineering and technology fields. Full article

The history of metallic orthopedic materials spans a few centuries, from the use of carbon steel to the widespread adoption of titanium and its alloys. This paper explores the evolution of these materials, emphasizing their mechanical properties, biocompatibility, and the roles that they have played in improving orthopedic care. Key developments include the discovery of titanium’s osseointegration capability, the advent of porous coatings for osseointegration, surface modifications, and the rise of additive manufacturing for patient-specific implants. Beyond titanium, emerging materials such as biodegradable alloys, tantalum, zirconium, and amorphous metals are creating a completely new field of application for orthopedic metals. These innovations address longstanding challenges, including stress shielding, corrosion, and implant longevity, while leading the way for bioresorbable and 3D-printed patient-specific solutions. This paper concludes by examining future trends and their potential for industrial application. By understanding the historical developments in metallic orthopedic materials, this review highlights how past advancements have laid the foundation for both current and future innovations, guiding research towards solutions that better mimic the properties of biological tissues, offer higher reliability in vivo, and enable patient-specific treatments. Full article

Laser micro-machining is a rapidly growing technique to create, manufacture and fabricate microstructures on different materials ranging from metals and ceramics to polymers. Micro- and nano-machining on different materials has been helpful and useful for various biomedical applications. This study focuses on the micro-machining of innovative barbed sutures using an ultrashort pulse laser, specifically a femtosecond (fs) laser system. Two bioresorbable polymeric materials, namely, catgut and poly (4-hydroxybutyrate) (P4HB), were studied and micro-machined using the femtosecond (fs) laser system. The optimized laser parameter was used to fabricate two different barb geometries, namely, straight and curved barbs. The mechanical properties were evaluated via tensile testing, and the anchoring performance was studied by means of a suture–tissue pull-out protocol using porcine dermis tissue which was harvested from the medial dorsal site. Along with the evaluation of the mechanical and anchoring properties, the thermal characteristics and degradation profiles were assessed and compared against mechanically cut barbed sutures using a flat blade. The mechanical properties of laser-fabricated barbed sutures were significantly improved when compared to the mechanical properties of the traditionally/mechanically cut barbed sutures, while there was not any significant difference in the anchoring properties of the barbed sutures fabricated through either of the fabrication techniques. Based on the differential scanning calorimetry (DSC) results for thermal transitions, there was no major impact on the inherent material properties due to the laser treatment. This was also observed in the degradation results, where both the mechanically cut and laser-fabricated barbed sutures exhibited similar profiles throughout the evaluation time period. It was concluded that switching the fabrication technique from mechanical cutting to laser fabrication would be beneficial in producing a more reproducible and consistent barb geometry with more precision and accuracy. Full article

Arterial diseases (ADs) are a significant health problem, with high mortality and morbidity rates. Endovascular interventions, such as balloon angioplasty (BA), bare-metal stents (BMSs), drug-eluting stents (DESs) and drug-coated balloons (DCBs), have made significant progress in their treatments. However, the issue has not been fully resolved, with restenosis remaining a major concern. In this context, bioresorbable vascular stents (BVSs) have emerged as a promising area of investigation. This manuscript includes articles that assess the use of BVSs. Studies have identified ongoing challenges, such as negative vascular remodeling and elastic recoil post-angioplasty, stent-related injury, and in-stent restenosis following BMS placement. While DESs have mitigated these issues to a considerable extent, their durable structures are unable to prevent late stent thrombosis and delay arterial recovery. BVSs, with their lower support strength and tendency towards thicker scaffolds, increase the risk of scaffold thrombosis. Despite inconsistent study results, the superiority of BVSs over DESs has not been demonstrated in randomized trials, and DES devices continue to be the preferred choice for most cases of arterial disease. Esprit BTK (Abbott Vascular) received approval from the US FDA for below-knee lesions in 2024, offering hope for the use of BVSs in other vascular conditions. Enhancing the design and thickness of BVS scaffolds may open up new possibilities. Large-scale and longer-term comparative studies are still required. This article aims to provide an overview of the use of biodegradable stents in the endovascular treatment of vascular stenosis. Full article

This review explores the advancements in additive manufacturing (AM) of biodegradable iron (Fe) and zinc (Zn) alloys, focusing on their potential for medical implants, particularly in vascular and bone applications. Fe alloys are noted for their superior mechanical properties and biocompatibility but exhibit a slow corrosion rate, limiting their biodegradability. Strategies such as alloying with manganese (Mn) and optimizing microstructure via laser powder bed fusion (LPBF) have been employed to increase Fe’s corrosion rate and mechanical performance. Zn alloys, characterized by moderate biodegradation rates and biocompatible corrosion products, address the limitations of Fe, though their mechanical properties require improvement through alloying and microstructural refinement. LPBF has enabled the fabrication of dense and porous structures for both materials, with energy density optimization playing a critical role in achieving defect-free parts. Fe alloys exhibit higher strength and hardness, while Zn alloys offer better corrosion control and biocompatibility. In vitro and in vivo studies demonstrate promising outcomes for both materials, with Fe alloys excelling in load-bearing applications and Zn alloys in controlled degradation and vascular applications. Despite these advancements, challenges such as localized corrosion, cytotoxicity, and long-term performance require further investigation to fully harness the potential of AM-fabricated Fe and Zn biodegradable implants. Full article

Background: The performance of an everolimus-eluting bioresorbable scaffold (BRS) was inferior to an everolimus-eluting metallic drug-eluting stent (DES) with permanent polymer, mainly due the mechanical features of BRS technology. The performance of BRS as compared to metallic DES with bioresorbable polymers remains unstudied. Methods: This prospective, randomized, multicenter, clinical trial enrolled patients who underwent coronary stenting for de novo coronary lesions. Patients were randomly assigned to bioresorbable polymer everolimus-eluting stents (BP-EES) or everolimus-eluting BRS. The primary endpoint was percentage diameter stenosis (in-device) at 6- to 8-month angiographic surveillance. The main secondary endpoint was the device-oriented composite endpoint (DOCE) of cardiac death/target vessel-myocardial infarction/target lesion revascularization assessed after 12 months and 5 years. Results: The trial was prematurely terminated after the enrollment of 117 of 230 patients (BP-EES, n = 60; BRS, n = 57) due to safety issues associated with BRS technology. The primary endpoint of in-device diameter stenosis at angiographic surveillance was 12.5 ± 7.7% with BP-EES versus 19.3 ± 16.5% with BRS (p = 0.01). The DOCE occurred in 5.0% in the BP-EES group versus 12.3% of patients in the BRS group (hazard ratio [HR] 2.48, 95% confidence interval [CI] 0.64–9.58, p = 0.19) after 12 months and in 11.7% in the BP-EES group versus 26.4% of patients in the BRS group (HR 2.38, 95% CI 0.97–5.84, p = 0.06) after 5 years. Conclusions: BP-EES showed superior mid-term angiographic performance compared with BRS. Clinical event rates did not differ significantly between the groups up to 5 years of follow-up. These results should be interpreted with caution in view of the premature discontinuation of the study. Full article

Bioresorbable magnesium-metal vascular stents are gaining popularity due to their biodegradable nature and good biological and mechanical properties. They are also suitable candidate materials for biodegradable stents. Due to the rapid degradation rate of Mg metal vascular scaffolds, a Mg/Zn bilayer composite was formed by a number of means, such as magnetron sputtering and physical vapor deposition, thus delaying the degradation time of the Mg metal vascular scaffolds while providing good radial support for the stenotic vessels. However, the interlaminar compounds at the metal interface have an essential impact on the mechanical properties of the bi-material interface, especially the cracking and delamination of the Mg matrix Zn coating vascular stent in the radially expanded process layer. Intermetallic compounds (IMCs) are commonly found in dual-layer composites, such as Mg/Zn composites and multi-layer structures. They are frequently overlooked in simulations aiming to predict mechanical properties. This paper analyses the interfacial failure processes and evolutionary mechanisms of interfacial fracture mechanics of a Mg/Zn interface with an intermetallic compound layer between coated Zn and Mg matrix metallic vascular stents. The simulation results show that the fracture mode in the Mg/Zn interface with an intermetallic compound involves typical ductile fracture under static tensile conditions. The dislocation line defects mainly occur on the side of the Mg, which induces the Mg/Zn interfacial crack to expand along the interface into the pure Mg. The stress intensity factor and the critical strain energy release rate decrease as the intermetallic compound layer’s thickness gradually increases, indicating that the intensity of stress and the force of the crack extending and expanding along the crack tip are weakened. The presence of intermetallic compounds at the interface can significantly strengthen the mechanical properties of the material interface and alleviate the crack propagation between the interfaces. Full article

Background and Objectives: Percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) is often associated with longer total stent length. Our aim was to evaluate the long-term safety and effectiveness of bioresorbable scaffold (BRS) implantation in CTO to avoid using a full metal jacket. Materials and Methods: We conducted a single-center prospective longitudinal case study including 34 patients who underwent PCI of CTO with at least one BRS and drug-eluting stent (DES) implantation (n = 27) or BRS-only at the Latvian Centre of Cardiology between 2016 and 2018. Quantitative coronary angiography (QCA) and intravascular ultrasound were performed during the index procedure and long-term follow-up. Results: Of 34 patients with a mean age of 60.6 ± 9.5 years, 76.5% were male. The most common CTO artery was the right coronary artery (73.5%, n = 25). The median length of occlusion was 23.0 mm (interquartile range (IQR) = 13.9–32.7), with a total mean BRS/DES length of 49.6 ± 20.4 mm. During the median follow-up of 5.6 years (IQR = 5.0–5.9), the primary endpoint of target vessel re-occlusion occurred in 5.9% (n = 2) of patients. Target lesion revascularization (TLR) was performed in 35.3% (n = 12) of patients, with a mean time to TLR of 62.5 (95% confidence interval (CI), 53.9–71.2) months. Through QCA, there was a statistically significant increase in median residual diameter stenosis (20.1–31.4%, p < 0.01) and residual length of stenosis (5.2–7.1%, p = 0.04) compared with the index procedure. Conclusions: Our study demonstrates that BRS is a safe and feasible option for PCI of CTO, allowing for the avoidance of long segment stenting and ensuring long-term patency of the coronary artery. Full article

Background: The acute coronary syndrome (ACS) continues to be a fundamental indication for revascularization by percutaneous coronary intervention (PCI). Drug-eluting stent (DES) implantation remains a part of contemporary practice but permanent caging of the vascular structure with the metallic stent structure may increase the rate of device-related adverse clinical events. As an alternative to classic metallic DESs, the bioresorbable scaffolds (BRSs) have emerged as a temporary vascular support technology. We evaluated the mid-term outcomes of two generations of bioresorbable scaffolds—Absorb (Abbott-Vascular, Chicago, IL, USA) and Magmaris (Biotronik, Germany)—in patients with non-ST-elevation ACS. Methods: The study cohort consisted of 193 subjects after Magmaris implantation and 160 patients following Absorb implantation in large-vessel lesions. Results: At 2 years, a significantly lower rate of a primary outcome (cardiac death, myocardial infarction, stent thrombosis) was observed with Magmaris (5.2% vs. 15%; p = 0.002). In addition, we observed a significantly lower rate of MI in the target vessel (2.6% vs. 9.4%; p = 0.009) and a lower rate of scaffold thrombosis (0% vs. 3.7%; p = 0.008). The TLF rate between the two groups was not significantly different. Conclusion: Magmaris demonstrated a good safety profile and more favorable clinical outcomes when compared to Absorb in patients with non-ST-elevation ACS. Full article

Background and Objectives: Spring-assisted surgery is a popular option for the treatment of non-syndromic craniosynostosis. The main drawback of this procedure is the need for a second surgery for spring removal, which could be avoided if a distractor material could be metabolised over time. Iron–Manganese alloys (FeMn) have a good trade-off between degradation rate and strength; however, their biocompatibility is still debated. Materials and Methods: In this study, the neuro-compatibility of Fe-20Mn (wt.%) was assessed using standard assays. PC-12 cells were exposed to Fe-20Mn (wt.%) and stainless steel via indirect contact. To examine the cytotoxicity, a Cell Tox Green assay was carried out after 1, 2, and 3 days of incubation. Following differentiation, a neurite morphological examination after 1 and 7 days of incubation time was carried out. The degradation response in modified Hank’s solution at 1, 3, and 7 days was investigated, too. Results: The cytotoxicity assay showed a higher toxicity of Fe-20Mn than stainless steel at earlier time points; however, at the latest time point, no differences were found. Neurite morphology was similar for cells exposed to Fe-20Mn and stainless steel. Conclusions: In conclusion, the Fe-20Mn alloy shows promising neuro-compatibility. Future studies will focus on in vivo studies to confirm the cellular response to Fe-20Mn. Full article

Magnesium alloys are promising materials for bioresorbable implants that will improve patient life and reduce healthcare costs. However, their clinical use is prevented by the rapid degradation and corrosion of magnesium, which leads to a fast loss of mechanical strength and the formation of by-products that can trigger tissue inflammation. Here, a tannic acid coating is proposed to control the degradation of AZ31 and AZ91 alloys, starting from a previous study by the authors on AZ91. The coatings on the two materials were characterized both by the chemical (EDS, FTIR, XPS) and the morphological (SEM, confocal profilometry) point of view. Static degradation tests in PBS and electrochemical measurements in different solutions showed that the protective performances of the tannic acid coatings are strongly affected by the presence of cracks. The presence of fractures in the protective layer generates galvanic couples between the coating scales and the metal, worsening the corrosion resistance. Although degradation control was not achieved, useful insights on the degradation mechanisms of coated Mg surfaces were obtained, as well as key points for future studies: it resulted that the absence of cracks in protective coatings is of uttermost importance for novel biodegradable implants with proper degradation kinetics. Full article

In the last decades, researchers have been developing bioresorbable stents (BRS) to overcome the long-term complications of drug-eluting stents (DES). However, BRS technology still presents challenging limitations in terms of manufacturing, materials, or mechanical properties. At this juncture, companies have developed ultrathin DES that may further improve the efficacy and safety profile of traditional DES by reducing the risk of target-lesion and target-vessel failures until BRS are developed. Nonetheless, the metallic platform of ultrathin DES still presents problems related to their cellular response. The use of polymers as a permanent platform in DES has not previously been studied due to the limitations of current manufacturing technologies. In this work, an innovative manufacturing method for polymeric stent production using tubular stereolithography (SLA) technology is proposed both for BRS and for ultrathin polymeric DES. The effects of manufacturing process parameters were studied by modelling the outcomes (stent thickness and strut width) with the key manufacturing variables (exposure, resin volume, and number of layers). Two different laser setups were used to compare the results. Microscopy results proved the merit of this novel tubular SLA process, which was able to obtain stents with 70 μm strut width and thickness in barely 4 min using only 0.2 mL of resin. Differential Scanning Calorimetry (DSC) results showed the stability of the manufacturing method. The results obtained with this innovative technology are promising and overcome the limitations of other previously used and available technologies. Full article

Magnesium AZ31 alloy has been chosen as bio-resorbable temporary prosthetic implants to investigate the degradation processes in a simulating body fluid (SBF) of the bare metal and the ones coated with low and high-molecular-weight PEO hydrogels. Hydrogel coatings are proposed to control the bioresorption rate of AZ31 alloy. The alloy was preliminary hydrothermally treated to form a magnesium hydroxide layer. 2 mm discs were used in bioresorption tests. Scanning electron microscopy was used to characterize the surface morphology of the hydrothermally treated and PEO-coated magnesium alloy surfaces. The variation of pH and the mass of Mg²⁺ ions present in the SBF corroding medium have been monitored for 15 days. Corrosion current densities (I_corr) and corrosion potentials (E_corr) were evaluated from potentiodynamic polarisation tests on the samples exposed to the SBF solution. Kinetics of cumulative Mg ions mass released in the corroding solution have been evaluated regarding cations diffusion and mass transport parameters. The initial corrosion rates for the H- and L-Mw PEO-coated specimens were similar (0.95 ± 0.12 and 1.82 ± 0.52 mg/cm²day, respectively) and almost 4 to 5 times slower than that of the uncoated system (6.08 mg/cm²day). Results showed that the highly swollen PEO hydrogel coatings may extend into the bulk solution, protecting the coated metal and efficiently controlling the degradation rate of magnesium alloys. These findings focus more research effort on investigating such systems as tunable bioresorbable prosthetic materials providing idoneous environments to support cells and bone tissue repair. Full article

There is a growing interest in tissue engineering, in which biomaterials play a pivotal role in promoting bone regeneration. Furthermore, smart functionalization can provide biomaterials with the additional role of preventing orthopedic infections. Due to the growing microbial resistance to antimicrobials used to treat those infections, metal ions, such as silver, thanks to their known wide range of bactericidal properties, are believed to be promising additives in developing antibacterial biomaterials. In this work, novel poly(ε-caprolactone) (PCL)-based 3D scaffolds have been designed and developed, where the polymer matrix was modified with both silver (Ag), to supply antibacterial behavior, and calcium phosphates (biphasic calcium phosphate, BCP) particles to impart bioactive/bioresorbable properties. The microstructural analysis showed that constructs were characterized by square-shaped macropores, in line with the morphology and size of the templating salts used as pore formers. Degradation tests demonstrated the important role of calcium phosphates in improving PCL hydrophilicity, leading to a higher degradation degree for BCP/PCL composites compared to the neat polymer after 18 days of soaking. The appearance of an inhibition halo around the silver-functionalized PCL scaffolds for assayed microorganisms and a significant (p < 0.05) decrease in both adherent and planktonic bacteria demonstrate the Ag+ release from the 3D constructs. Furthermore, the PCL scaffolds enriched with the lowest silver percentages did not hamper the viability and proliferation of Saos-2 cells. A synergic combination of antimicrobial, osteoproliferative and biodegradable features provided to 3D scaffolds the required potential for bone tissue engineering, beside anti-microbial properties for reduction in prosthetic joints infections. Full article