A family of specialty polymers to meet industry demand for metal alternatives that provide optimal performance and meet the requirements of long-term or permanent exposure to body fluids and tissues in the human body. These samples provide the exceptional performance of safe and reliable materials for a number of implant fields including Orthopedics, Cardiology, Spine, Sports Medicine, Limbs, Trauma, and more. These polymers include:
Polysulfone
It is a transparent polymer, also available in matte white, which offers strong toughness and biocompatibility. This polymer maintains its dimensional tolerance right out of the mold and does not require machining. Polysulfone is a rigid thermoplastic that does not absorb liquids and is suitable for MRI imaging.
Polyphenylsulfone
It provides unparalleled toughness along with excellent clarity and biocompatibility.
Polyetheretherketone is one of the most stable plastics available with high strength and stiffness, as well as excellent toughness and wear resistance. This polymer meets the requirements of ASTM F2026-07 as a polymer for surgical implant applications.
Polyetheretherketone
It has a modulus of elasticity that is similar to that of cortical bone and minimizes the loss of bone density by maintaining normal pressure on the surrounding bone tissue. Offers excellent biocompatibility. It also eliminates the risk of allergic reactions to heavy metals, and its radiolucent properties will not interfere with X-ray and computed tomography scanning methods.
All the above materials can be sterilized using conventional methods such as gamma rays, ethylene oxide, and steam. They show no evidence of cytotoxicity, sensitization, intradermal reaction, or acute systemic toxicity, based on biocompatibility testing according to ISO 10993:1. These sterilizable products are available in grades for injection molding or extrusion as well as stock shapes for machined parts.
Specialty polymers for implantable devices meet the highest industry standards for safety and quality. Only products designated as part of the specialty polymer family can be considered candidates for medical applications implanted in the human body and devices that are in contact with body fluids or tissues for more than 24 hours.
Characteristics of specialized polymers for implantable devices
Outstanding structural properties
Specialized thermoplastics for implantable devices have the highest standards of strength and durability. For example, polyetheretherketone, which is used in a wide range of cages and spacers for anterior and posterior fusions, offers exceptional strength and toughness. The load-bearing reliability of medical grade polyetheretherketone makes it an excellent material for stabilizing structures and long-term fasteners, as it outperforms metal in its stiffness-to-weight ratio. In addition, polyphenylsulfone provides exceptional toughness and strength in applications such as valves and shunts that treat hydrocephalus.
Dimensional stability
The dimensional integrity of polysulfone and polyphenylsulfone provides excellent moldability and manipulation into rigid and complex shapes for a range of cardiovascular, neurovascular, and dental applications. The flexibility of polysulfone does not require expensive machining. It provides the ability to produce more cost-effective parts for vascular and injection access ports compared to other commercial materials. In addition, polyphenylsulfone offers exceptional moldability and is easily used for the optimal production of wire and lead coatings.
Impenetrability and chemical resistance
Implantable devices have a structure that can often be adapted to body tissues and fluids, as well as a variety of medical materials. To withstand the harsh conditions and chemical exposure that implantable medical devices face, specialized polymers for implantable devices are designed with impermeable and chemically resistant properties. Polysulfone is impermeable, which makes it ideal for injection ports. In addition, polyphenylsulfone provides excellent chemical resistance that is optimal for wire and lead coatings in valves and shunts that help regulate the necessary pressure-based fluid flow.
Optimal transparency
High-performance polymers are equipped with radiolucency properties. Polyetheretherketone provides implantable devices with radiolucent components to provide exceptional visibility for X-rays, CT scans, MRIs, and other imaging modalities. The transparent quality of polysulfone and polyphenylsulfone also allows for unobstructed imaging, surpassing the previous capabilities of lower-performing materials.
