34 THE DISTRIBUTOR’S LINK Del Williams Del Williams is a technical writer based in Torrance, California. He writes about health, business, technology, and educational issues, and has an M.A. in English from C.S.U. Dominguez Hills. IMPLANT RELIES ON UNIQUE FASTENER TO GEAR UP FOR BABY BOOMER GENERATION To handle active baby boomers and rising longevity, Skeletal Dynamics specifies an innovative self locking fastener that withstands up to one-million loading cycles for its new elbow replacement implant As the first of the baby boomer generation turns 65 this year and promises to live longer and more actively than previous generations, implants and their components - including the fasteners that hold them together - must be built to last longer than ever before. To handle the demands of tomorrow’s dynamic baby boomer population, for whom jogging, tennis, and golf have been generational pursuits, some medical device companies are going beyond what’s currently required. For instance, some are specifying self locking fasteners in implants of the upper extremities that go way beyond 100,000 load cycles to withstand up to one-million load cycles without loosening or backing out. “Patients are living longer and more vigorously than past generations, and that’s only going to increase as baby boomers demand more from their muscular-skeletal systems well past traditional ‘retirement age,’” says Tom Norman, Vice President of Engineering at Miami, Fla.-based Skeletal Dynamics, a designer and marketer of innovative orthopedic devices. To keep up with active baby boomers, Skeletal Dynamics recently developed its Align Radial Head System, an artificial elbow joint designed to restore the natural function of the native radial head. Previously, prosthetic radial head designs typically followed one of two approaches with significant drawbacks. While a traditional fixed monoblock design offered stability, it could not be aligned to the patient’s anatomy, which tended to wear away natural tissue such as cartilage. A bi-polar radial head was an attempt to align with the patient’s native anatomy, as it was able to rotate in a polyethylene sheath, but would not remain in the correct position because it would not lock. “We aimed to fill a gap in the market by providing the ability to orient the joint to its natural position during surgery, and then locking it in place for the rest of the patient’s life,” says Norman. “We considered traditional fastener thread forms, but lacked confidence that they would stay in place for the up to a million load cycles an active patient could subject them to in their lifetime. Instead, we selected an innovative self locking fastener called Spiralock.” Because repetitive loads, shock and loosening must be decisively handled for implant use, traditional fasteners susceptible to self-loosening rotational movement, stripping, and shearing are not always appropriate. Testing, in fact, has found that the first two threads of traditional fasteners can carry as much as 80% of the load, permitting stripping or shearing, while subsequent male threads "float" within the female threads. please turn to page 190
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