For many years, torque-applying instruments have been among the surgical instruments typically used during orthopedic surgeries. These instruments are manufactured as reusable instruments, and are cleaned, reprocessed and recalibrated after each surgical procedure.
But now there's a new twist on this oft-used instrument. Caltorque Medical Products (CMP), a division of California Torque Products Inc., says its TorqueSafe™ torque instruments give surgical implant original equipment manufacturers (OEMs) an alternative to traditional reusable instruments.
"We have transitioned from what is traditionally a stainless steel instrument with a silicon over-molded handle to a mostly plastic, cost-effective alternative offering the same at-use performance," said Brian Cutler, vice president, marketing and product development, CMP.
Makrolon® polycarbonate resin from Bayer MaterialScience LLC forms the handles of CMP's TorqueSafe™ instruments, which are designed for trauma, reconstruction, small bone, cranio maxillofacial fixation, spine and extremity procedures.
"We selected Makrolon® polycarbonate because it met the robust requirements of the surgical setting and need for high-stress performance," explained Doug Slomski, vice president sales – medical products, Caltorque Medical Products Division.
According to Slomski, other advantages included the material's compatibility with sterilization modalities, ability to meet care and handling requirements, durability in transport, and global availability. "Also important was the material's ability to exceed in-use environmental and in-situ conditions," he continued.
The ability to repurpose materials post-use was yet another benefit of using the Makrolon® polycarbonate resin, since it can be incorporated into the health care community's recycling programs and procedures, according to CMP.
"The TorqueSafe™ instrument is a good illustration of how our customers are taking a fresh, innovative approach to health care technology," said Bruce Fine, market segment leader – medical, North America, Bayer MaterialScience LLC. "We recognize CMP for their forward thinking and are pleased to play a role in bringing to market an instrument that can contribute to an improved experience for the physician and patient."
Ratcheting up the benefits
TorqueSafe™ allows a surgeon to apply the correct tightening force to screws, up to a preset value, and not allowing the screw to be over tightened, according to CMP. The ergonomics of the design are a symmetrical T and an offset T, offering the physician the choice of which best fits the application or grip preference. The handles are injection molded from Makrolon® 2458 medical grade polycarbonate, an easy-flow polycarbonate with easy-release characteristics, good hydrolysis resistance and biocompatible according to ISO 10993-1 test requirements.
"For decades the health care industry has turned to our polycarbonate resins to bring ground-breaking products to market," said Richard Aldrich, field market development manager, North America, Bayer MaterialScience LLC. "The good processability and optimal flow rate of this polycarbonate grade, along with many other desirable properties, made it a good fit for this application."
There are two versions of the TorqueSafe™ instrument. The first is designed specifically for a single procedure. The second version is designed for multiple procedures: It can be used in several surgeries until the proprietary TorqueSafe™ mechanism disables the instrument, preventing additional use. The multiple-procedure version will withstand multiple cleanings and autoclave cycles, but will not need calibration, explains Slomski. Both versions exhibit the TorqueSafe™ alert window, giving users a visual indication of in-calibration use and end-of-calibration disablement.
According to CMP, TorqueSafe™ instruments enable the OEM to reduce or eliminate the reprocessing cycle cost associated with reusable surgical instruments while offering an instrument that can fit the recycle/repurposing initiatives of hospitals around the world.
Attendees at the MD&M West Conference and Exposition, Feb. 10-12, can visit Bayer's booth (#2021) for more details about Bayer's material solutions for medical applications.
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