Originally Published MPMN November 2005
Plastics and Elastomers
A company supplies biocompatible implantable-grade and medical-grade PEEK polymers to medical device manufacturers. A high-performance biomaterial, the PEEK-Optima is suitable for use in the development of implantable medical devices that require blood or tissue contact in excess of 30 days. Alternatively, the PEEK-Classix polymer is a thermoplastic designed for applications that involve blood or tissue contact for fewer than 30 days, such as catheters, surgical instruments, analytical equipment, and blood-management and drug-delivery systems. The chemically resistant PEEK polymer allows for repeat sterilization via conventional methods, such as steam, gamma radiation, and EtO processes, without degradation of its mechanical properties.
Invibio, Greenville, SC
A photocurable polymer coating is suited for guidewires and catheters for cardiovascular and urological applications. Features of the coating include minimal friction, wear resistance, and biocompatibility with minimal leaching. The product is appropriate for a range of substrates, including heat-sensitive materials such as polyvinyl chloride, polyurethane, and polyamide. Selected properties can be tailored to suit specific applications.
DSM Medical Coatings, Heerlen, Netherlands
Ranging in particle size from 0.08 to 850 µm, powdered materials are available for use in research or prototype development. A supplier of more than 200 polymers, metals, ceramics, alloys, and compounds in powdered form offers small quantities, from several grams to kilos, of the powdered materials. Custom-made alloys are available and manufacturing techniques can vary depending on the specified composition.
Goodfellow Corp., Devon, PA
A company’s medical-grade plastics are employed in an assortment of applications, including medical wands, sterilization trays, and endoscopic probes and devices. Many of the company’s semifinished plastic shapes incorporate Radel R polyphenylsulfone, an amorphous thermoplastic possessing good impact and chemical resistance. Other products supplied by the company include Ultem PEI, polysulfone, Acetron GP FDAColors, Rulon 641, PEEK, and Tygon, silicone, and polyimide microbore tubing used in cardiovascular catheters, urological retrieval devices, intravascular drug delivery, balloon angioplasty, and stent delivery. The plastics meet FDA and USP Class VI standards.
Professional Plastics Inc., Fullerton, CA
Antistatic thermoplastic compounds
Antistatic thermoplastic compounds enable repeatable powder and aerosol dosages to flow through inhalation devices while retaining clarity. ABS, acrylic, and cyclic olefin copolymers are being used in such applications as an alternative to acetal, a polymerized form of formaldehyde. The antistatic compounds retain electrostatic-discharge properties amid humidity and neutralize the effect of static in the drug-delivery path in order to ensure that patients receive the proper dosage.
RTP Co., Winona, MN
Thermoplastic polyurethane elastomers
PVC-free, soft thermoplastic polyurethane elastomers are suited for use in injection molding and extrusion processing. Neuthane N8511 compounds offer flexibility, abrasion resistance, long flex life, oil resistance, and elongation of 700% or 1000% perpendicular to machine direction, according to the company. Available in 63 Shore A hardness, the elastomers also feature tensile breaking strength of 2800 psi. Currently used as a sheath cover for a laproscopic surgery medical device manufacturer, the materials also can be employed in such applications as surgical devices that minimize insertion cavities in the body.
New England Urethane Inc., North Haven, CT
Copyright ©2005 Medical Product Manufacturing News