Polymers for Implantable Devices
Due to the growing demand for implantable devices, there is also a growing demand for approved materials for use in manufacturing these devices. Polymers are an increasingly important material for use in medical implantable devices, with UHMW PE and PEEK being the most popular.
The Implantable Device Market
According to the FDA, implants are defined as devices intended to stay within the body for more than 30 days. Implantable devices are an ever growing market that was already worth $96.6 billion back in 2018 and expected to reach $143.3 Billion by 2024. These implantable devices include joint replacements, deep brain neurostimulators, pacemakers, insulin pumps, gastric stimulators, and more.
Requirements for Implantable Device Materials
When it comes to materials, the implantable device market is divided into metals, ceramics, polymers, and biologics. For implant materials to be considered safe, they must remain stable in the presence of body fluids, not elicit an adverse response from the host, and, if applicable, meet requirements related to strength, stiffness, and performance. Long-term long-term biostability and biocompatibility are also key, as well as compatibility with medical imaging methods. For load bearing implants such as those used in hip replacements, how a polymer responds to wear can also be critical.
The two most widely used implantable polymers are FDA approved grades of UHMW PE (Ultra-High Molecular Weight Polyethylene) and PEEK (Polyether ether ketone), although there are other polymers in use.
UHMW PE for Implantables
UHMW PE has been in use for orthopedic applications for over 30 years. UHMW PE can be found in joint replacements and spinal disc implants, where properties such as a low coefficient of friction, excellent fatigue resistance, and good impact strength are vital. Its primary drawback is a lack of strength, which is why it is not used in applications that involve significant load bearing. Note that UHMW PE can be machined or molded, but cannot be injection molded.
PEEK for Implantables
Implantable PEEK offers some properties similar to UHMW PE, including good impact strength and a low coefficient of friction. It is also self-lubricating, possesses a high compression strength, and offers good wear resistance. As a matrix material combined with carbon and graphite fibers, it can be customized to offer improved properties related to strength, stiffness, and dimensional stability. Unlike UHMW PE, PEEK is more versatile when it comes to manufacturing: it can be machined, molded, extruded, and even powder coated. One of PEEK’s more recent applications is implantable spinal cages, which requires significant load bearing capacity.
Other Implantable Polymers
Other polymers for implantables include PSU (Polysulfone), which is known for its toughness, dimensional stability, and moldability. PSU can be found in implantable devices such as shunts and access ports. Another polymer is PPSU (Polyphenylsulfone), which combines toughness with transparency and is often used as a coating for wires and leads. Both of these polymers also provide excellent tensile strength and biocompatibility.
Materials for use in implantable devices must be stringent requirements, and for good reason. There are a host of issues, such as biocompatibility, biostability, wear properties, friction, stiffness, and strength, that all depend heavy on the application. However, there are polymers such as UHMW PE and PEEK whose performance and safety have been well established.