Applications of Polyethylene Glycol (PEG) as Medical Devices

Applications of Polyethylene Glycol (PEG) as Medical Devices

Polyethylene glycol (PEG) is known as the best biocompatible synthetic polymer material which is colorless, odorless, with low toxicity, low immunogenicity, good water solubility and biocompatibility. PEG is an FDA-approved synthetic polymer with precise molecular weight, high purity, and low dispersion. In addition to being used in the long-term effect and enhancement of drugs, hydrogels made of PEG materials have also been comprehensively applied in the field of medical devices, including the adhesion, hemostasis, anti-leakage, and anti-adhesion of wounds in various surgical operations, as well as being used as raw materials for implantable medical devices, replacing existing plant, animal, or human materials. BOC Sciences offers a range of PEG and medical device solutions that are designed to enhance the performance, safety, and efficacy of medical devices. We offer a range of surface modification technologies that can improve the biocompatibility and functionality of medical devices. These include plasma treatment, ion implantation, and chemical surface modification. BOC Sciences also provides various biocompatibility testing services to ensure that medical devices are safe and effective for use in humans, including cytotoxicity, sensitization, irritation, and implantation testing.

Introduction of PEG Hydrogels

Hydrogel is a kind of hydrophilic polymer cross-linked network system that fully swells in water but does not dissolve. It has the characteristics of softness, high water content, elasticity, and high biocompatibility. As a new type of soft and wet materials, hydrogels have attracted great attention in recent years in the fields of biosensing, drug delivery, tissue engineering, soft robot, etc. PEG hydrogels have the potential to prevent non-specific protein adsorption, making them one of the excellent biomaterials available for human use. In accordance with the purpose of use, hydrogels can perform different functions, such as leakage prevention, wound sealing/hemostasis, or preventing adhesion of organs. In addition, it can be used as a slow-release system, where a drug-containing hydrogel is transplanted or injected into an organism and then released into the body fluid for controlled release. PEG hydrogels have good physical and chemical properties, low toxicity, and high biocompatibility, which can be gradually degraded in the human body and completely expelled. They are used in various medical scenarios and have a broad prospect.

Research applications of PEG hydrogels in medical devicesFig. 1. Research applications of PEG hydrogels in medical devices (Journal of Controlled Release. 2021, 330: 575-586).

Applications of PEG Hydrogels

Surgical Wound Closure and Hemostasis

Surgical wound closure and hemostasis are the main applications of PEG gel products, including ophthalmology, imaging, spine, and other surgical scenarios. When the hydrogel based on PEG derivatives is sprayed into the wound, it quickly solidifies, prevents bleeding and infection, and degrades after the wound heals. At the same time, if the hydrogel is sprayed onto the surface of the organs, it can effectively prevent the adhesion of internal organs during the operation. Due to the good biocompatibility of PEG derivatives, this process will not cause abnormal reactions in the human body. And they will be metabolized out of the body instead of being absorbed.

Applications of Polyethylene Glycol (PEG) as Medical Devices

Baxter's marketed CoSeal, for example, has a gel component consisting of PEG and polyethylene that, when sprayed onto tissue surfaces, rapidly cross-links with proteins on the surface and forms a mechanical adhesion that quickly seals blood vessel sutures and reduces air leakage when applied in lung surgery. The DuraSeal products from Covidien are designed to assist in the sealing of the dura mater after suturing in neurosurgery. DuraSeal consists of 4-arm PEG aqueous solution and aqueous lysine solution. After the two components are mixed and sprayed on the wound surface, the solution can be quickly cross-linked into PEG hydrogel on the surface of human tissue to seal the dura suture and prevent the leakage of cerebrospinal fluid. It can be decomposed by the human body within 4 to 8 weeks. As the first dural sealant approved for craniotomy in the United States, DuraSeal has excellent tissue adhesion properties and the incidence of cerebrospinal fluid leakage rate after use is only 1/4 of that of traditional fibrin glue. Designed with safety and patient comfort in mind, Cardinal Health's MYNX vascular closure device series use PEG polymer as a seal against the vessel wall that gently closes wounds without clamping, suturing, or metal implants. The seal fully degrades within 30 days of arterial healing.

Cell Isolation in Radiotherapy

Cell isolation in radiotherapy is a leading field of PEG gel applications. When radiotherapy is used to treat cancer patients, the injection of PEG gel between tissues can isolate different tissues, effectively reducing the dose of radiation reaching other healthy tissues and killing cancer cells while avoiding damage to surrounding healthy tissues. SpaceOAR, produced by Boston Scientific's Augmenix, Inc., launched in 2015, is the first tissue-isolating product in the U.S. for radiotherapy for prostate cancer. The gel comes in the form of a water injection that quickly forms a solid gel between the prostate and rectum, pushing the organs away from each other by about 1.3 centimeters. The extra space created reduces the dose of radiation that can affect the rectum during prostate radiotherapy, thereby reducing the risk of rectal damage. Clinical studies have shown that SpaceOAR can reduce rectal mucosal damage from 90% to 13.6% in patients receiving high-dose radiotherapy. Patients who receive SpaceOAR before radiotherapy have a 73.5% reduction in late radiation toxicity or rectal damage during the three-year follow-up.

Applications of Polyethylene Glycol (PEG) as Medical Devices

Filling Instruments

In addition, PEG hydrogels can be used to prepare absorbable implantable drug slow-release systems. They are also being used to develop self-healing injectable hydrogels with antibacterial and angiogenic properties, which can be used for eye disease treatment, skin wound repair due to diabetes, and 3D cell culture.

At present, PEG hydrogels as medical devices are extensively used worldwide. The number of PEG gel projects under development is increasing, and it is expected that their applications will be further expanded in the future. BOC Sciences can provide regulatory support for medical device companies, including assistance with FDA submissions, compliance with international standards, and product registration. Our one-stop service platform can provide the most comprehensive solution for any medical device development project applied to PEG.

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