Remember Grandpa Joe, who got a steel plate in his head after being hit with shrapnel during World War II?
If Grandpa Joe had the same injury today, he’d probably get a polymer-based custom-fit replacement made with a three-dimensional printer for that steel plate. The implant technology developed by Oxford Performance Materials, based in South Windsor, CT, combines high-performance polymers with 3-D printing to create specific skull implants. It received approval from the U.S. Food and Drug Administration (FDA) in February, reports Medical Daily.
3-D printing, also known as additive manufacturing, is the process by which a machine lays down material, often polymers, in layers. A computer program tells the printer where to put the layers so that, after many cycles, they form a three-dimentional shape.
The advantage of making a skull implant from a 3-D printer is that it can be shaped for each individual use, and be built quickly. Medical Daily explains more:
3D printed implants advantage is the possibility to use an individually scanned model of a patient’s skull, directly from CT scans or MRI, to ‘print out’ a matching 3D object layer by layer. The precise manufacturing technique can even make tiny surface or edge details on the replacement part that encourage the growth of cells and allow skin to attach more easily.
About 300 to 500 people in the United States need skull bone replacements every month, mostly because they suffer from cancerous bone or head trauma. The company plans to expand the use of 3-D-printed skull replacements to other bones of the human body. Now that FDA has approved the use of the skull implant by surgeons, the company is preparing to request that FDA approve the 3-D printing for other human bone implants as well.
To make the implants, the company uses a printing machine from EOS, a company in Munich, Germany. The machine is the first to use the polymer, polyetherketoneketone (PEKK), as the print material for human bone implants. Researchers believe that PEKK is uniquely suited for bone implants because it is biocompatible, similar to bone, and is radiolucent, meaning that it does not interfere with X-ray equipment.
The company also has completed tests that its implant material is osteoconductive, meaning that new bone can attach to it and grow. “It is our firm belief that the combination of PEKK and additive manufacturing is a highly transformative and disruptive technology platform that will substantially impact all sectors of the orthopedic industry,” says Scott DeFelice, president and CEO of Oxford Performance Materials.
Source: “3D-Printed Polymer Skull Implant Used for First Time in US,” Medical Daily, 3/7/13
Image by Chris Dodds.