Electrospinning of Potential Medical Devices (Wound Dressings, Tissue Engineering Scaffolds, Face Masks) and Their Regulatory Approach

Abstract

Electrospinning is the simplest and most widely used technology for producing ultra-thin fibers. During electrospinning, the high voltage causes a thin jet to be launched from the liquid polymer and then deposited onto the grounded collector. Depending on the type of the fluid, solution and melt electrospinning are distinguished. The morphology and physicochemical properties of the produced fibers depend on many factors, which can be categorized into three groups: process parameters, material properties, and ambient parameters. In the biomedical field, electrospun nanofibers have a wide variety of applications ranging from medication delivery systems to tissue engineering scaffolds and soft electronics. Many of these showed promising results for potential use as medical devices in the future. Medical devices are used to cure, prevent, or diagnose diseases without the presence of any active pharmaceutical ingredients. The regulation of conventional medical devices is strict and carefully controlled; however, it is not yet properly defined in the case of nanotechnology-made devices. This review is divided into two parts. The first part provides an overview on electrospinning through several examples, while the second part focuses on developments in the field of electrospun medical devices. Additionally, the relevant regulatory framework is summarized at the end of this paper.

Spontaneous Recycling of Electrosprayed Sample by Retrograde Motion of Microdroplets

“…32 In the positive ESI mode, the surface of the liquid cone is positively charged due to the electrostatic repulsion. 33,34 The liquid spindle�polarized by a strong electric field�breaks up and generates a series of negatively (closer to the meniscus) and positively (farther from the meniscus) charged droplets through varicose instabilities and fission processes. 14,15,20,29 If the electric charge of a droplet is not enough for the electrostatic repulsion from the cone to the counter electrode, the droplet could be attracted back to the liquid meniscus due to the droplet's negative net charge.…”

“…Zhou and Cook noted that electrophoretic separation of ions can lead to an axial charge gradient, and it can persist in the electrosprayed droplets at least until the first droplet fission . In the positive ESI mode, the surface of the liquid cone is positively charged due to the electrostatic repulsion. , The liquid spindlepolarized by a strong electric fieldbreaks up and generates a series of negatively (closer to the meniscus) and positively (farther from the meniscus) charged droplets through varicose instabilities and fission processes. ,,, If the electric charge of a droplet is not enough for the electrostatic repulsion from the cone to the counter electrode, the droplet could be attracted back to the liquid meniscus due to the droplet’s negative net charge. We examined this behavior by adding different electrolytes into the solution (Table ).…”

Electrospun Naringin-Loaded Fibers for Preventing Scar Formation during Wound Healing

“…Biatain ® Alginate advanced dressing has showed a more hydrophilic behavior with a non-detectable wettability and high percentage of SWF absorbency according to its hydrophilic polymeric composition. As already mentioned in the introduction, an ideal advanced dressing must provide a correct moisture balance to create a healing in a humid condition and prevent the risk of maceration and eschar formation [ 9 , 10 ]. Based on this evidence, Biofiber and Biofiber NG provides optimal exudate management performance.…”

“…In this context, nano-fiber dressings have great potential for providing most of the ideal dressing features [ 9 ]. In addition, the electrospun dressing can imitate the extracellular matrix; regulate the cellular responses of skin, including proliferation, migration, and differentiation, drastically reducing the healing time of injuries and facilitating the healing of complex injuries.…”

Synergistic Combination of Antimicrobial Peptides and Cationic Polyitaconates in Multifunctional PLA Fibers

“…Electrospinning has emerged as a well-established and versatile technology for producing submicron-sized fibers, which provides numerous advantages such as a high surface-to-volume ratio. These electrospun fiber mats serve as physical barriers, preventing microbial penetration while facilitating oxygen and gas transfer, especially important for wound dressing applications . Moreover, the high surface area of these fiber mats enables the incorporation of bioactive molecules, including antimicrobial compounds, thereby reducing the risk of infections.…”