For high-performance athletes, a torn anterior cruciate ligament (ACL) can end a career. Part of the problem in treating ACL injuries with medical appliances is the uniqueness of every knee. Until 3D printing, it was cost prohibitive to shape a medical tool or appliance to match the anatomy of each and every patient.
Dr. Dana Piasecki, an orthopedic surgeon at OrthoCarolina Sports Medicine, in Charlotte, N.C., experimented with various surgical techniques aimed at improving graft positioning in ACL surgery. His efforts led to the development of the Pathfinder System, which consists of the Pathfinder ACL Guide and Guide Pins. The guide and the pins are anatomically matched to the patient’s knee.
The Pathfinder ACL Guide, (available from DanaMed Inc.) is a biocompatible surgical device that helps surgeons better reconstruct partially or fully torn ACL ligaments and reduce the risk of re-tearing.
Dr. Piasecki refined the design using Fused Deposition Modeling (FDM). But then, Dr. Piasecki needed a manufacturing process that could efficiently produce the complex surgical instrument at an affordable price and provide the freedom necessary to make design changes on the fly. Stratasys Direct Manufacturing, a provider of additive (3D printing) and conventional manufacturing services, met these requirements and now builds the metal tool using Direct Metal Laser Sintering (DMLSTM) technology.
“Pathfinder illustrates how 3D printing is uniquely capable of enabling breakthroughs in medical technology that otherwise would not be possible,” said John Self, project engineer at Stratasys Direct Manufacturing. “And by saving DanaMed more than 97% in costs over conventional manufacturing methods, 3D printing has demonstrated its business value in bringing complex, high-quality parts to market.”
The Pathfinders are printed with Inconel 718 material, which achieved the necessary biocompatibility, surface finish, oil resistance and mechanical requirements. After extensive testing, the Pathfinder System was registered with the FDA as a Class 1 Medical Device. Pathfinders are now on the market and being used by orthopedic surgeons across the country.
With a 95% success rate of anchoring grafts in their native ACL locations, DanaMed’s Pathfinder System is a potential game-changer for ACL repair surgeries. Anchoring grafts in this way allows repaired ACLs to handle the same stress as a natural ACL once could. Other methods are more difficult to perform and can increase both the potential for surgical complications and risk of reinjuring the knee.
Like DanaMed, more and more companies are manufacturing metal parts using 3D printing. In fact, a recent survey sponsored by Stratasys Direct Manufacturing, “3D Printing’s Imminent Impact on Manufacturing,” found additive metal usage in the U.S. is expected to nearly double over the next three years.