By Michael Goglia, Americas Healthcare Market Manager, Elkem Silicones
Silicone based adhesives continue to play a major role in the advancement of medical devices. Silicones have long been a material of choice for MedTech OEM’s and fabricators due to their inherent properties of biocompatibility, chemical inertness, environmental stability, and high performing physical properties. Elkem Silicones has continued to work with our customer base to develop the next generation of high performing adhesives and address unmet performance and biocompatibility needs.
Hurdles that exist when designing these devices include creating a bond between differing substrates, developing a robust and cost-effective manufacturing process, and ensuring these materials meet the current and future regulatory landscape for patient safety. The advancement of silicone-based adhesives can further widen the range of materials available for use when designing devices and create new possibilities for the future of patient health. We also see the tendency for lower temperature curing requirements becoming more prevalent as the technologies within become more sensitive to heat.
When developing our range of medical grade adhesives, one of the first areas of focus for our team was the assembly of neuro-engineering, or neuromodulation devices. These devices often require the coupling of distinctly different materials to achieve successful design in addressing hearing loss, chronic pain, Parkinson’s disease, dementia, Alzheimer’s, obesity, and even sleep apnea. While there are many different material choices available to engineers to use in development of such devices, the options for fastening them together are limited.
Neuomodulation devices generally include a metallic electrode that is encased in an insulative silicone sleeve and/or thermoplastic sheath to deliver a controlled electrical signal to a targeted area. They can also be encased in titanium or ceramic casings to be watertight and stable. More sensitive electrode arrays continue to be used and require increased flexibility driving device developers to broaden their scope of metal and elastomeric materials used in design and manufacture process. This creates adhesion difficulties that didn’t previously exist.
Elkem Silicones has worked with our customer base and R&I departments to advance the solutions available and allow more material flexibility to overcome limitations in device design. Depending on the assembly process and material constraints, we have different product options available. A mono-component, tin free version referred to as Silbione™ Biomedical ADH1 M200 and a 2-part, addition cure system referred to as Silbione™ Biomedical ADH2 M213 are available in several cure variations to support temperature sensitive substrates or components. These materials are suited for applications exceeding 29 days within the body, such as implants, and have been formulated to meet stringent biocompatibility requirements needed for this marketplace.
By conducting internal peel tests using these adhesives and various substrates, the Elkem Silicones team has been able to achieve cohesive failure results on many thermoplastic polyurethane substrates, metallic substrates, and other silicone polymers without the use of surface treatments or primers. With more difficult substrates we have several tools available that we can recommend to our customer base to get the desired results, including one or a combination of the following: OpenAir Plasma treatment, Plasma treatment, and/or the addition of our Silbione™ M&P Primer.
Elkem Silicones has found that when using mentioned above processing time can be greatly reduced compared to similar, competitive adhesives currently on the marketplace for biomedical applications. For the mono-component Silbione™ Biomedical ADH1 M200, we have found that tack free time can be cut in half vs. comparable products under ambient conditions (without the addition of humidity). Given that we continue to see increased scrutiny from regulatory bodies on the usage of tin as a catalyst in healthcare applications for mono-component silicone adhesives, our team used an alternative to tin in our silicone adhesive product.
The Silbione™ Biomedical ADH2 M213 has been designed under three separate cure conditions that can be accelerated with heat. Our QC (quick cure) version cures in less than 30 minutes at room temperature, the standard version cures in two hours or less and our slow cure version cures in 19 hours or less. These different cure times allow for flexibility during processing based on the device manufacturing requirements.
Silbione™ Biomedical grade silicones meet the highest quality and manufacturing standards, complying with the Elkem Silicones Quality Management System. This includes:
- Attestations and toxicological Summaries (available upon request)
- Master Access File (MAF) with FDA CRDH for Silbione™ Biomedical products
- Elkem Silicones clean operation standards following GMP principles and ISO14949 guidelines
- Certified ISO Class 8 manufacturing environment and ISO Class 7 packaging environment for Silbione™ Biomedical products
- Responsible care management system
Discover our medical grade adhesive solutions, backed by Elkem’s Silbione™ brand for high quality, clean manufacturing, and regulatory support. Contact us through our Website or call 866-474-6342 to learn more about how Silbione™ silicone solutions can help you improve your productivity, performance, and expand your range of applications.
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