Manufacture Of Implantable Devices Research Articles

Recent advances in materials and manufacturing of implantable devices for continuous health monitoring

Implantable devices are vital in healthcare, enabling continuous monitoring, early disease detection, informed decision-making, enhanced outcomes, cost reduction, and chronic condition management. These devices provide real-time data, allowing proactive healthcare interventions, and contribute to overall improvements in patient care and quality of life. The success of implantable devices relies on the careful selection of materials and manufacturing methods. Recent materials research and manufacturing advancements have yielded implantable devices with enhanced biocompatibility, reliability, and functionality, benefiting human healthcare. This paper provides a comprehensive overview of the latest developments in implantable medical devices, emphasizing the importance of material selection and manufacturing methods, including biocompatibility, self-healing capabilities, corrosion resistance, mechanical properties, and conductivity. It explores various manufacturing techniques such as microfabrication, 3D printing, laser micromachining, electrospinning, screen printing, inkjet printing, and nanofabrication. The paper also discusses challenges and limitations in the field, including biocompatibility concerns, privacy and data security issues, and regulatory hurdles for implantable devices.

Effects of the Manufacturing Methods on the Mechanical Properties of a Medical-Grade Copolymer Poly(L-lactide-co-D,L-lactide) and Poly(L-lactide-co-ε-caprolactone) Blend.

Biocompatible and biodegradable polymers represent the future in the manufacturing of medical implantable solutions. As of today, these are generally manufactured with metallic components which cannot be naturally absorbed within the human body. This requires performing an additional surgical procedure to remove the remnants after complete rehabilitation or to leave the devices in situ indefinitely. Nevertheless, the biomaterials used for this purpose must satisfy well-defined mechanical requirements. These are difficult to ascertain at the design phase since they depend not only on their physicochemical properties but also on the specific manufacturing methods used for the target application. Therefore, this research was focused on establishing the effects of the manufacturing methods on both the mechanical properties and the thermal behavior of a medical-grade copolymer blend. Specifically, Injection and Compression Molding were considered. A Poly(L-lactide-co-D,L-lactide)/Poly(L-lactide-co-ε-caprolactone) blend was considered for this investigation, with a ratio of 50/50 (w/w), aimed at the manufacturing of implantable devices for tendon repair. Interesting results were obtained.

Biocompatible Nanocomposites Based on Poly(styrene-block-isobutylene-block-styrene) and Carbon Nanotubes for Biomedical Application.

In this study, we incorporated carbon nanotubes (CNTs) into poly(styrene-block-isobutylene-block-styrene) (SIBS) to investigate the physical characteristics of the resulting nanocomposite and its cytotoxicity to endothelial cells. CNTs were dispersed in chloroform using sonication following the addition of a SIBS solution at different ratios. The resultant nanocomposite films were analyzed by X-ray microtomography, optical and scanning electron microscopy; tensile strength was examined by uniaxial tension testing; hydrophobicity was evaluated using a sessile drop technique; for cytotoxicity analysis, human umbilical vein endothelial cells were cultured on SIBS–CNTs for 3 days. We observed an uneven distribution of CNTs in the polymer matrix with sporadic bundles of interwoven nanotubes. Increasing the CNT content from 0 wt% to 8 wt% led to an increase in the tensile strength of SIBS films from 4.69 to 16.48 MPa. The engineering normal strain significantly decreased in 1 wt% SIBS–CNT films in comparison with the unmodified samples, whereas a further increase in the CNT content did not significantly affect this parameter. The incorporation of CNT into the SIBS matrix resulted in increased hydrophilicity, whereas no cytotoxicity towards endothelial cells was noted. We suggest that SIBS–CNT may become a promising material for the manufacture of implantable devices, such as cardiovascular patches or cusps of the polymer heart valve.

An insight on type I collagen from horse tendon for the manufacture of implantable devices

Type I collagen is the most abundant protein of the human body. Due to its favourable properties, collagen extracted from animal tissues is adopted to manufacture a wide range of devices for biomedical applications. Compared to bovine and porcine collagens, which are the most largely used, equine collagen is free from the risk of zoonosis, has no reported immune reactions, and has not religious constraints. In this work, a recently available type I collagen extracted from horse tendon was evaluated and compared with a commercially available collagen isoform derived from the same species and tissue. Detailed physical, chemical and biological investigations were performed, in agreement with the requirements of the current standard for the characterization of type I collagen to be used for the manufacture of Tissue Engineering Medical Products. To the best of our knowledge, this is the first report on the complete primary structure of the investigated collagen.

A study of physical and biological properties of 3D matrices made from polytrimethylene carbonate and its copolymers

The development of new materials for using in different parts of medicine (for replacement of affected vessels, cartilage, connective, glandular tissue) has recently become widespread, due to the high rate of occurrence of these pathologies and the need for surgical treatment of these pathologies. One of the promising approaches is the production of tissue engineered matrices from various polymers and their mixtures by the electrospinning. Block polymers (for example, trimethylene carbonate) are of particular interest for fabrication of tissue engineered devices due to the ability to customize the polymer stability by using different sets of blocks. 3D matrices were prepared from solutions of polytrimethylene carbonate (PTMC) and its copolymers with polycaprolactone and lactic acid in various solvents (dichloromethane with dimethylformamide, pure dichloromethane or hexafluoroisopropanol) by electrospinning. Scaffolds were prepared from mixtures of polymers with gelatin. The structure of the matrices was characterized by the scanning electron microscopy method. Hydrophilicity and mechanical strength of the matrices were investigated. The ability of primary human umbilical vein endothelial cells (HUVEC) to attach and proliferate on the surfaces of different matrices was studied. The tensile strength of the matrices, produced from dichloromethane solutions was not more than 0.22 MPa, and the strength of the scaffolds produced from hexafluoroisopropanol solutions reached 4.3 MPa. HUVEC successfully attached to the matrices, but proliferation rate was slow. During storage the matrices produced from the PTMC and its copolymers had a tendency to absorb water vapor, and exhibited shrinkage, fusion of the fibers and strength loss. 3D matrices produced from PTMC cannot be recommended for the manufacture of implantable devices but can tentatively serve as biodegradable scaffolds in tissue engineering without constant hydrodynamic loading, such as areas of connective or glandular tissue.

Osteoanabolic Implant Materials for Orthopedic Treatment.

Osteoporosis is becoming more prevalent due to the aging demographics of many populations. Osteoporotic bone is more prone to fracture than normal bone, and current orthopedic implant materials are not ideal for the osteoporotic cases. A newly developed strontium phosphate (SrPO4 ) coating is reported herein, and applied to Ti-29Nb-13Ta-4.6Zr (wt%), TNTZ, an implant material with a comparative Young's modulus to that of natural bone. The SrPO4 coating is anticipated to modulate the activity of osteoblast (OB) and osteoclast (OC) cells, in order to promote bone formation. TNTZ, a material with excellent biocompatibility and high bioinertness is pretreated in a concentrated alkaline solution under hydrothermal conditions, followed by a hydrothermal coating growth process to achieve complete SrPO4 surface coverage with high bonding strength. Owing to the release of Sr ions from the SrPO4 coating and its unique surface topography, OB cells demonstrate increased proliferation and differentiation, while the cellular responses of OC are suppressed, compared to the control case, i.e., bare TNTZ. This TNTZ implant with a near physiologic Young's modulus and a functional SrPO4 coating provides a new direction in the design and manufacture of implantable devices used in the management of orthopedic conditions in osteoporotic individuals.