Biocompatibility, material strength and supplier support led OrthoSensor Inc. of Sunrise, Fla., to select Makrolon Rx1851 polycarbonate to house components of a device for use during total knee-replacement surgery.
The “knee balancer” provides surgeons with real-time quantitative intraoperative data on soft tissue balancing during arthroplasty. Previously, a surgeon subjectively needed to determine the amount of pressure to apply to a knee implant.
Material supplier Bayer MaterialScience LLC of Pittsburgh worked with an adhesives formulator and injection molder to safeguard the medical-grade PC's integrity, said Bruce Fine. Fine is Bayer market segment leader for PC medical and consumer products in Pittsburgh.
Custom translucent formulations in brown, green, blue and yellow indicate a specific surgical size.
OrthoSensor introduced the intelligent orthopedic device in late 2011 in the U.S. market.
The knee balancer was among developments that Bayer presented during the Medical Design & Manufacturing West trade show, held Feb. 14-16 in Anaheim.
Specialty pharmaceutical firm Intelliject Inc. of Richmond, Va., is developing a highly portable user-friendly epinephrine autoinjector, under its e-cue brand, for patients at risk for severe allergic reactions. The Food and Drug Administration granted tentative approval in August.
Fine said Bayer worked with Intelliject for several years to advance the device.
Bayer's medical-grade Makrolon 2458 PC is used for the device's thin outer cover. Bayblend M850 and Bayblend M850XF PC/ABS blends are used for the electrical cover, white housing and top, and a red safety guard. M850XF also is used for the part that touches a patient during injection.
During MD&M, Bayer introduced a non-reinforced, flame-retardant, amorphous Bayblend M303FR PC/ABS blend for use in medical diagnostic equipment including scanners for computed tomography, magnetic resonance imaging, and positron emission tomography. Resin production takes place in a Newark, Ohio, facility.
Available for extrusion, blow molding and thermoforming processes, M303FR is useful for surface device applications contacting skin and meets ISO cytotoxicity and irritation-sensitization guidelines.
Fine discussed Bayer's medical antimicrobial plastics portfolio, which addresses the rise of health-care-associated infections and can help prevent bacteria or fungi from degrading a product.
The plant in Newark produces pelletized forms of Makrolon PC grades AM1825, AM2428 and AM2520 and Bayblend PC/ABS grade AM120FR primarily for injection molding.