Fabrication Of Medical Devices Research Articles

Assembly of Silicate-Phenolic Network Coatings with Tunable Properties for Controlled Release of Small Molecules.

Engineered coatings are pivotal for tailoring the surface properties and release profiles of materials for applications across diverse areas. However, developing robust coatings that can both encapsulate and controllably release cargo is challenging. Herein, a dynamic covalent coordination assembly strategy is used to engineer robust silicate-based coatings, termed silicate-phenolic networks (SPNs), using sodium metasilicate and phenolic ligands (tannic acid, gallic acid, pyrogallol). The coatings are pH-responsive (owing to the dynamic covalent bonding), and their hydrophobicity can be tuned upon their post-functionalization with hydrophobic gallates (propyl, octyl, lauryl gallates). The potential of the SPN coatings for the controlled release of small molecules, such as urea (a widely used fertilizer), is demonstrated-controlled release of urea in soil is achieved in response to different pHs (up to 7 days) and different hydrophobicity (up to 14 days). Furthermore, leveraging the presence of silicon (within the coating) and post-functionalization of the SPN coatings with metal ions (Fe3+, Cu2+, Zn2+) generates a multipurpose delivery system for the sustained release of micronutrient fertilizers, and silicon and metal ions, over 28 and 14 days, respectively. These SPN coatings have potential applications beyond agriculture, including nutrient delivery, separations, food packaging, and medical device fabrication.

Biocompatibility of 3D-printed vs. thermoformed and heat-cured intraoral appliances.

The development of additive manufacturing has the potential to revolutionize the fabrication of medical devices. This technology, also known as 3D printing, offers precise, cost-effective, and personalized approaches, which could be particularly beneficial in the production of intraoral appliances. Despite its promise, research on the biocompatibility of 3D-printed intraoral devices is still limited. Our study aims to address this gap. We examined the cytotoxicity of materials processed via three techniques commonly used for the fabrication of different intraoral appliances: 3D printing (Dental LT Clear), thermoforming (Duran adjusted with Durasplint LC), and conventional heat-curing (Villacryl H Plus). We also investigated the impact of chemical or UVC disinfection on the biocompatibility of these materials. We assessed the biological effects induced in human gingival fibroblasts (HGFs) through both direct contact tests (MTT and LDH assays) and extract tests (PrestoBlue, DCF, and cell death type assays). Additionally, we observed changes in cellular morphology and migration rate under an inverted light microscope. The surface roughness of materials was evaluated using contact profilometry. Statistical analysis was conducted using two-way analysis of variance. Our findings suggest that all three fabrication techniques induced a slight cytotoxic effect in HGFs, as evidenced by both direct contact and extract tests. However, these materials could be considered nontoxic according to the ISO 10993-5:2009 norm, as the decrease in metabolic activity observed was always less than 30% compared to the untreated control. This novel study confirms that 3D printing may be a safe alternative to conventional methods for fabricating intraoral appliances. However, further tests assessing the long-term intraoral usage are still needed.

MediKnit: Soft Medical Making for Personalized and Clinician-Designed Wearable Devices for Hand Edema

Current rapid prototyping in medical domains relies on rigid 3D-printed materials, lacking flexibility, customization, and clinician-led input. This paper introduces MediKnit, a novel approach for the fabrication of soft medical devices, addressing critical limitations in existing design processes for medical devices. MediKnit provides a design tool empowering clinicians to personalize fabric-based devices for hand edema. This tool allows clinicians to adapt the design to individual patients' demands, thereby enhancing the overall effectiveness of therapy. The MediKnit device created by this tool consists of a machine-knit glove with active compression, which is programmable through a custom PCB. This device facilitates the mobilization of edema. To illustrate the practical implementation of our approach, this paper presents case studies involving six patients experiencing hand edema. The results demonstrate the adaptability and feasibility of our process for developing soft medical devices, highlighting its potential to broaden accessibility, facilitate personalized solutions, and empower clinicians as active medical makers.

Revolutionizing healthcare materials: Innovations in processing, advancements, and challenges for enhanced medical device integration and performance

Cutting-edge materials have transformed the fabrication of medical devices and implants. However, the processing used to create these materials impacts their mechanical, physical, and biological characteristics, preventing effective integration. This study is intended to provide a detailed analysis of healthcare materials processing techniques, stressing healthcare-specific material requirements, such as biocompatibility, mechanical strength, corrosion resistance, stabilizability, and bioactivity, followed by classifying these processing methods as “ordinary” and “edge-cutting” methods. The consequences of each processing on the material, as well as the benefits, drawbacks, and recent developments of each technique, are also aimed to be concluded. The study also aimed to explore how process factors affect product qualities. The articles are collected from the Scopus and Web of Science databases using the search strings “Advance Material,” “Material Processing,” “Healthcare,” and “HealthCare Application.” The assessment of the selected literature has been done in accordance with the objectives. The assessment emphasizes quality assurance and regulatory compliance by stressing the need for quality assurance, characterization, and testing for medical devices and implants. Processes such as polishing, etching, and coatings improve biocompatibility and reduce infection risk, according to the findings. It was also concluded that cutting-edge processing methods such as additive manufacturing (3D printing) and electrospinning provide exact control over material composition, structure, and porosity, making them ideal for many clinical applications.

Biopolymeric Innovations in Ophthalmic Surgery: Enhancing Devices and Drug Delivery Systems.

The interface between material science and ophthalmic medicine is witnessing significant advances with the introduction of biopolymers in medical device fabrication. This review discusses the impact of biopolymers on the development of ophthalmic devices, such as intraocular lenses, stents, and various prosthetics. Biopolymers are emerging as superior alternatives due to their biocompatibility, mechanical robustness, and biodegradability, presenting an advance over traditional materials with respect to patient comfort and environmental considerations. We explore the spectrum of biopolymers used in ophthalmic devices and evaluate their physical properties, compatibility with biological tissues, and clinical performances. Specific applications in oculoplastic and orbital surgeries, hydrogel applications in ocular therapeutics, and polymeric drug delivery systems for a range of ophthalmic conditions were reviewed. We also anticipate future directions and identify challenges in the field, advocating for a collaborative approach between material science and ophthalmic practice to foster innovative, patient-focused treatments. This synthesis aims to reinforce the potential of biopolymers to improve ophthalmic device technology and enhance clinical outcomes.

Performance of bioresorbable peptide incorporated polymers produced for fused deposition modelling (FDM)

The use of biomaterials in additive manufacturing (AM) of medical devices has gained significant attention over the years, especially in areas such as wound care and orthopedics. This study aims to investigate the performance of bioresorbable peptide-incorporated polymers produced for fused deposition modelling (FDM) process. Herein, we report FDM 3D Printing process of bioactive polymers comprising polycaprolactone (PCL), poly(lactic-co-glycolic acid) (PLGA) or polylactic acid (PLA) or blended with peptide–containing brush copolymers bearing similar synthetic polymer side chains. Mechanical, thermal and rheological properties of the materials were carried out and we report that the incorporation of bioactive polymers into these biodegradable polymers does not result in significant changes to glass transition temperature, melt temperature, tensile properties of the base polymers. However, it was observed that flexural and rheological properties altered significantly. This study provides an insight into the thermomechanical performance of bioresorbable peptide-incorporated polymers for FDM utilization which allows for their use potential in medical device fabrication.

Preparation of cellulose-PCC fibre hybrids: Use as filler in polypropylene (PP) composites

Abstract Polymer composite materials find application in various life sectors such as packaging, lightweight construction and the fabrication of medical devices. Functional fillers like mineral colloids, synthetic and natural fibres enable a precise tailoring of the mechanical properties of the resulting compounds. Precipitated calcium carbonate (CaCO3, PCC) has proven to be a special popular mineral polymer filler. From economic and ecologic reasons, it is desirable to increase filler contents in polymers while maintaining material strength. To achieve this, the present work has developed a hybrid filler system which is based on carboxymethylated, fibrillated cellulose fibres. CaCO3 is precipitated onto the fibres in a single step twin-screw extrusion process by the co-precipitation method. This process ensures a strong, permanent interaction between the fibres and the mineral particles, which enables CaCO3 contents in the filler of up to 68 wt.-%. The resulting hybrid fillers were compounded with polypropylene (PP) in a powder or paste state with filler contents between 5 wt.-% and 20 wt.-%. The resulting composites show an increase in the zero-shear viscosity and, in the event of sufficient network formation, a marked increase in stiffness was observed.

Nanostructured Medical Devices: Regulatory Perspective and Current Applications.

Nanomaterials (NMs) are having a huge impact in several domains, including the fabrication of medical devices (MDs). Hence, nanostructured MDs are becoming quite common; nevertheless, the associated risks must be carefully considered in order to demonstrate safety prior to their immission on the market. The biological effect of NMs requires the consideration of methodological issues since already established methods for, e.g., cytotoxicity can be subject to a loss of accuracy in the presence of certain NMs. The need for oversight of MDs containing NMs is reflected by the European Regulation 2017/745 on MDs, which states that MDs incorporating or consisting of NMs are in class III, at highest risk, unless the NM is encapsulated or bound in such a manner that the potential for its internal exposure is low or negligible (Rule 19). This study addresses the role of NMs in medical devices, highlighting the current applications and considering the regulatory requirements of such products.

Enhancing the Weld Quality of Polylactic Acid Biomedical Materials Using Rotary Friction Welding.

Polylactic acid (PLA) stands out as a biomaterial with immense potential, primarily owing to its innate biodegradability. Conventional methods for manufacturing PLA encompass injection molding or additive manufacturing (AM). Yet, the fabrication of sizable medical devices often necessitates fragmenting them into multiple components for printing, subsequently requiring reassembly to accommodate the constraints posed by the dimensions of the AM platform. Typically, laboratories resort to employing nuts and bolts for the assembly of printed components into expansive medical devices. Nonetheless, this conventional approach of jointing is susceptible to the inherent risk of bolts and nuts loosening or dislodging amid the reciprocating movements inherent to sizable medical apparatus. Hence, investigation into the joining techniques for integrating printed components into expansive medical devices has emerged as a critical focal point within the realm of research. The main objective is to enhance the joint strength of PLA polymer rods using rotary friction welding (RFW). The mean bending strength of welded components, fabricated under seven distinct rotational speeds, surpasses that of the underlying PLA substrate material. The average bending strength improvement rate of welding parts fabricated by RFW with three-stage transformation to 4000 rpm is about 41.94% compared with the average bending strength of PLA base material. The average surface hardness of the weld interface is about 1.25 to 3.80% higher than the average surface hardness of the PLA base material. The average surface hardness of the weld interface performed by RFW with variable rotational speed is higher than the average surface hardness of the weld interface performed at a fixed rotating friction speed. The temperature rise rate and maximum temperature recorded during RFW in the X-axis of the CNC turning machine at the outer edge of the welding part surpassed those observed in the internal temperature of the welding part. Remarkably, the proposed method in this study complies with the Sustainable Development Goals due to its high energy efficiency and low environmental pollution.

Review on structural optimization techniques for additively manufactured implantable medical devices

Recent developments in additive manufacturing (AM) have led to significant opportunities in the design and fabrication of implantable medical devices due to the advantages that AM offers compared to conventional manufacturing, such as high customizability, the ability to fabricate highly complex shapes, good dimensional accuracy, a clean build environment, and reduced material usage. The study of structural design optimization (SDO) involves techniques such as Topology Optimization (TO), Shape Optimization (SHO), and Size Optimization (SO) that determine specific parameters to achieve the best measurable performance in a defined design space under a given set of loads and constraints. Integration of SDO techniques with AM leads to utmost benefits in designing and fabricating optimized implantable medical devices with enhanced functional performance. Research and development of various lattice structures represents a powerful method for unleashing the full potential of additive manufacturing (AM) technologies in creating medical implants with improved surface roughness, biocompatibility, and mechanical properties. Furthermore, the integration of artificial intelligence (AI) and machine learning (ML) in structural optimization has expanded opportunities to improve device performance, adaptability, and durability. The review is meticulously divided into two main sections, reflecting the predictability of the implant’s internal structure: (a) unpredictable interior topology, which explores topology-based optimization techniques, and (b) predictable inner topology, concentrating on lattice structures. The analysis of the reviewed literature highlights a common focus on addressing issues such as stress shielding, osseointegration enhancement, customization to individual needs, programmable functionalities, and weight reduction in implant designs. It emphasizes significant advances in reducing stress shielding effects, promoting osseointegration, and facilitating personalized implant creation. The review provides a detailed classification of optimization methods, with each approach scrutinized for its unique contribution to overcoming specific challenges in medical implant design, thus leading to more advanced, effective, and patient-oriented implantable devices.

Smart self-defensive coatings with bacteria-triggered antimicrobial response for medical devices.

Bacterial colonization and biofilm formation on medical devices represent one of the most urgent and critical challenges in modern healthcare. These issues not only pose serious threats to patient health by increasing the risk of infections but also exert a considerable economic burden on national healthcare systems due to prolonged hospital stays and additional treatments. To address this challenge, there is a need for smart, customized biomaterials for medical device fabrication, particularly through the development of surface modification strategies that prevent bacterial adhesion and the growth of mature biofilms. This review explores three bioinspired approaches through which antibacterial and antiadhesive coatings can be engineered to exhibit smart, stimuli-responsive features. This responsiveness is greatly valuable as it provides the coatings with a controlled, on-demand antibacterial response that is activated only in the presence of bacteria, functioning as self-defensive coatings. Such coatings can be designed to release antibacterial agents or change their surface properties/conformation in response to specific stimuli, like changes in pH, temperature, or the presence of bacterial enzymes. This targeted approach minimizes the risk of developing antibiotic resistance and reduces the need for continuous, high-dose antibacterial treatments, thereby preserving the natural microbiome and further reducing healthcare costs. The final part of the review reports a critical analysis highlighting the potential improvements and future evolutions regarding antimicrobial self-defensive coatings and their validation.

Facile method for 3D printing conformally onto uneven surfaces and its application to face masks

Conventional additive manufacturing processes, where parts are built through layer-wise deposition of material on a horizontal plane, can be limiting when a part must be printed or fit onto uneven surfaces. Such situations will arise with increasing frequency as additive manufacturing application areas such as construction and medical devices continue to grow. In this work, we develop a simple and practical approach to generate toolpaths to print 3D structures onto uneven surfaces conformally. The algorithm uses only conventional planar toolpaths of both the structure to be printed and the substrate to be printed on and converts these to non-planar toolpaths, allowing easy integration with existing additive manufacturing workflows. The technique is demonstrated by printing flexible seals onto bespoke rigid face mask frames conformally via a conventional single-material 3D printer using the generated conformal toolpath. A notable improvement in air seal performance was observed for customized face masks with conformal soft seals compared to conventionally 3D-printed fully rigid face masks. This also shows the potential of the developed toolpath generation method to aid in the prototyping and fabrication of conformal medical and other devices.

Single Component Polymers, Polymer Blends, and Polymer Composites for Interventional Endovascular Embolization of Intracranial Aneurysms.

Intracranial aneurysm is the abnormal focal dilation in brain arteries. When untreated, it can enlarge to rupture points and account for subarachnoid hemorrhage cases. Intracranial aneurysms can be treated by blocking the flow of blood to the aneurysm sac with clipping of the aneurysm neck or endovascular embolization with embolics to promote the formation of the thrombus. Coils or an embolic device are inserted endovascularly into the aneurysm via a micro-catheter to fill the aneurysm. Many embolization materials have been developed. An embolization coil made of soft and thin platinum wire called the "Guglielmi detachable coil" (GDC) enables safer treatment for brain aneurysms. However, patients may experience aneurysm recurrence because of incomplete coil filling or compaction over time. Unsatisfactory recanalization rates and incomplete occlusion are the drawbacks of endovascular embolization. So, the fabrication of new medical devices with less invasive surgical techniques is mandatory to enhance the long-term therapeutic performance of existing endovascular procedures. For this aim, the current article reviews polymeric materials including blends and composites employed for embolization of intracranial aneurysms. Polymeric materials used in embolic agents, their advantages and challenges, results of the strategies used to overcome treatment, and results of clinical experiences are summarized and discussed.

Fabrication of 3D-Printed Contact Lens Composed of Polyethylene Glycol Diacrylate for Controlled Release of Azithromycin.

Since three-dimensional (3D)-printed tablets were approved by the United States Food and Drug Administration (FDA), 3D printing technology has garnered increasing interest for the fabrication of medical and pharmaceutical devices. With various dosing devices being designed for manufacture by 3D printing, 3D-printed ophthalmic formulations to release drugs have been one such target of investigation. In the current study, 3D-printed contact lenses designed for the controlled release of the antibiotic azithromycin were produced by vat photopolymerization, and the effect of the printer ink composition and a second curing process was investigated. The azithromycin-loaded contact lenses were composed of the cross-linking reagent polyethylene glycol diacrylate (PEGDA), PEG 400 as a solvent, a photoinitiator, and azithromycin. The 3D-printed contact lenses were fabricated successfully, and formulations with lower PEGDA concentrations produced thicker lenses. The mechanical strength of the PEGDA-based contact lenses was dependent on the amount of PEGDA and was improved by a second curing process. Drug release from 3D-printed contact lenses was reduced in the samples with a second curing process. The azithromycin-loaded contact lenses exhibited antimicrobial effects in vitro for both Gram-positive and -negative bacteria. These results suggest that 3D-printed contact lenses containing antibiotics are an effective model for treating eye infections by controlling drug release.

Surface grafting of polymeric catheters and stents to prevent biofilm formation of pathogenic bacteria

BackgroundTecothane (medical grade of polyurethane) is strongly involved in the fabrication of metallic and polymeric-based medical devices (e.g., catheters and stents) as they can withstand cardiac cycle-related forces without deforming or failing, and they can mimic tissue behavior. The main problem is microbial contamination and formation of pathogenic biofilms on such solid surfaces within the human body. Accordingly, our hypothesis is the coating of tecothane outer surfaces with antibacterial agents through the electro-deposition or chemical grafting of anti-biofilm agents onto the stent and catheter surfaces. ResultsTecothane is grafted with itaconic acid for cross-linking the polyethyleneimine (PEI) as the protective-active layer. Accordingly, the grafting of poly-itaconic acid onto the Tecothane was achieved by three different methods: wet-chemical approach, electro-polymerization, or by using plasma treatment. The successful modifications were verified using Fourier Transform Infrared (FTIR) spectroscopy, grafting percentage calculations, electrochemical, and microscopic monitoring of biofilm formation. The grafting efficiency of itaconic acid was over 3.2% (w/w) at 60 ℃ after 6 h of the catheter chemical modification. Bio-electrochemical signals of biofilms have been seriously reduced after chemical modification because of the inhibition of biofilm formation (for both Pseudomonas aeruginosa and Staphylococcus aureus) over a period of 9 days. ConclusionChemical functionalization of the polyurethane materials with the antimicrobial and anti-biofilm agents led to a significant decrease in the formation of pathogenic biofilms. This promising proof-concept will open the door to explore further surface protection with potential anti-biofilm agents providing better and sustainable productions of stents and catheters biomaterials. Graphical Abstract▪

4D printing of biodegradable elastomers with tailorable thermal response at physiological temperature

4D printing has a great potential for the manufacturing of soft robotics and medical devices. The alliance of digital light processing (DLP) 3D printing and novel shape-memory photopolymers allows for the fabrication of smart 4D-printed medical devices in high resolution and with tailorable functionalities. However, most of the reported 4D-printed materials are nondegradable, which limits their clinical applications. On the other hand, 4D printing of biodegradable shape-memory elastomers is highly challenging, especially when transition points close to physiological temperature and shape fixation under ambient conditions are required. Here, we report the 4D printing of biodegradable shape-memory elastomers with tailorable transition points covering physiological temperature, by using poly(D,L-lactide-co-trimethylene carbonate) methacrylates at various monomer feed ratios. After the programming step, the high-resolution DLP printed stents preserved their folded shape at room temperature, and showed efficient shape recovery at 37 °C. The materials were cytocompatible and readily degradable under physiological conditions. Furthermore, drug-loaded devices with tuneable release kinetics were realized by DLP-printing with resins containing polymers and levofloxacin or nintedanib. This study offers a new perspective for the development of next-generation 4D-printed medical devices.

Design of experiment and machine learning inform on the 3D printing of hydrogels for biomedical applications

In the biomedical field, 3D printing has the potential to deliver on some of the promises of personalized therapy, notably by enabling point-of-care fabrication of medical devices, dosage forms and bioimplants. To achieve this full potential, a better understanding of the 3D printing processes is necessary, and non-destructive characterization methods must be developed. This study proposes methodologies to optimize the 3D printing parameters for soft material extrusion. We hypothesize that combining image processing with design of experiment (DoE) analyses and machine learning could help obtaining useful information from a quality-by-design perspective. Herein, we investigated the impact of three critical process parameters (printing speed, printing pressure and infill percentage) on three critical quality attributes (gel weight, total surface area and heterogeneity) monitored with a non-destructive methodology. DoE and machine learning were combined to obtain information on the process. This work paves the way for a rational approach to optimize 3D printing parameters in the biomedical field.

Applications of 3D printing in aging.

Aging is inevitable, and how to age healthily is a key concern. Additive manufacturing offers many solutions to this problem. In this paper, we first briefly introduce various 3D printing technologies commonly used in the biomedical field, particularly in aging research and aging care. Next, we closely examine aging-related health conditions of nervous system, musculoskeletal system, cardiovascular system, and digestive system with a focus on the application of 3D printing in these fields, including the creation of in vitro models and implants, production of drugs and drug delivery systems, and fabrication of rehabilitation and assistive medical devices. Finally, the opportunities, challenges, and prospects of 3D printing in the field of aging are discussed.

Exploring the value of three-dimensional printing and virtualization in paediatric healthcare: A multi-case quality improvement study.

Three-dimensional printing is being utilized in clinical medicine to support activities including surgical planning, education, and medical device fabrication. To better understand the impacts of this technology, a survey was implemented with radiologists, specialist physicians, and surgeons at a tertiary care hospital in Canada, examining multidimensional value and considerations for uptake. To examine how three-dimensional printing can be integrated into the paediatric context and highlight areas of impact and value to the healthcare system using Kirkpatrick's Model. Secondarily, to explore the perspective of clinicians utilizing three-dimensional models and how they make decisions about whether or not to use the technology in patient care. A post-case survey. Descriptive statistics are provided for Likert-style questions, and a thematic analysis was conducted to identify common patterns in open-ended responses. In total, 37 respondents were surveyed across 19 clinical cases, providing their perspectives on model reaction, learning, behaviour, and results. We found surgeons and specialists to consider the models more beneficial than radiologists. Results further showed that the models were more helpful when used to assess the likelihood of success or failure of clinical management strategies, and for intraoperative orientation. We demonstrate that three-dimensional printed models could improve perioperative metrics, including a reduction in operating room time, but with a reciprocal effect on pre-procedural planning time. Clinicians who shared the models with patients and families thought it increased understanding of the disease and surgical procedure, and had no effect on their consultation time. Three-dimensional printing and virtualization were used in preoperative planning and for communication among the clinical care team, trainees, patients, and families. Three-dimensional models provide multidimensional value to clinical teams, patients, and the health system. Further investigation is warranted to assess value in other clinical areas, across disciplines, and from a health economics and outcomes perspective.

Emerging 4D fabrication of next-generation nerve guiding conduits: a critical perspective.

The latest advancements in the field of manufacturing for biomedicine, digital health, targeted therapy, and personalized medicine have fuelled the fabrication of smart medical devices. Four-dimensional (4D) fabrication strategies, which combine the manufacturing of three-dimensional (3D) parts with smart materials and/or design, have proved beneficial in creating customized and self-fitting structures that change their properties on demand with time. These frontier techniques that yield dynamic implants can indeed alleviate various drawbacks of current clinical practices, such as the use of sutures and complex microsurgeries and associated inflammation, among others. Among various clinical applications, 4D fabrication has lately made remarkable progress in the development of next-generation nerve-guiding conduits for treating peripheral nerve injuries (PNIs) by improving the end-to-end co-aptation of transected nerve endings. The current perspective highlights the relevance of 4D fabrication in developing state-of-the-art technologies for the treatment of PNIs. Various 4D fabrication/bio-fabrication techniques for PNI treatment are summarized while identifying the challenges and opportunities for the future. Such advancements hold immense promise for improving the quality of life of patients suffering from nerve damage and the potential for extending the treatment of many other disorders. Although the techniques are being described for PNIs, they will lend themselves suitably to certain cases of cranial nerve injuries as well.