Engineers at Metric Medical Devices near San Antonio, Texas, needed a sterile, disposable, biocompatible housing for the company’s Super Stable Classic, a syringe-sized device that quickly implants nitinol staples into bone, allowing for shorter, less invasive surgeries, and speedier patient recovery times.
Offered as a complete procedure kit, the Super Staple offers instantaneous bone compression force in common surgeries such as hand and foot bone fragment and osteotomy fixation, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments.
After conducting property evaluations for several options for the device house, Metric Medical selected Makrolon Rx2530 from Bayer MaterialScience LLC because of the material’s high strength, temperature stability, transparency, and biocompatibility.
“The performance of Makrolon Rx2530 has been excellent,” says Dan Wadsworth, vice president, research and development, Metric. “The Bayer MaterialScience team was remarkably responsive during the material selection and design phase.”
In addition to assisting with material selection, Bayer also conducted testing to demonstrate the material’s compliance with ISO-10993 and U.S. Food and Drug Administration biocompatibility guidelines.
“We worked closely with Metric, providing guidance related to selection of the Makrolon polycarbonate grade that best met the stringent requirements – including toughness and biocompatibility – for this application,” says Fred Woods, field market development, Polycarbonate, Bayer MaterialScience.
Other medical material offerings
Makroblend EL4000 polycarbonate/polybutylene terephthalate (PC+PBT): EL4000 offers a high level of chemical resistance against many of the powerful disinfectants used to wipe down hospital room surfaces and equipment.
Makrolon Rx2440 polycarbonate: Rx2440 combines rigidity, toughness, high flow, and unique color-recovery after irradiation. Like all medical Makrolon polycarbonate grades, Rx2440 polycarbonate resin can be used in a variety of medical device applications.
Bayfol UX502 thermoplastic polyurethane (TPU) film: Used in medical packaging, it protects medical devices and provides the required high abrasion resistance of TPU and the ease of thermoforming provided by polyethylene terephthalate glycol-modified (PETG).
Platilon and Dureflex films: Dressings made with these films help protect wounds and accelerate healing with their high breathability. These films can also be used to make skin-friendly surgical drapes that conform to the patient’s body shape.
Baymedix A raw material: This adhesive is targeted for skin adherence in wound care.
Baymedix FP reactive foam technology: This solution enables the production of very smooth and conformable foams that are non-yellowing, have high absorption rates, and great fluid retention capability.
Bayer MaterialScience LLC
Metric Medical Devices Inc.