By Staff Reports
(DGIwire) – For anyone undergoing orthopedic surgery, a common concern is a complication called aseptic loosening. According to the American Academy of Orthopaedic Surgeons, this occurs where the bond between an implant and bone doesn’t hold, requiring patients to be taken back to surgery after a joint replacement. Now a team of researchers from the University of Waterloo in Ontario has pioneered a way to analyze the integrity of 3D-printed medical implants—ensuring they are of the highest quality before being put into a patient’s body.
In their study, published in the Journal of Materials Processing Technology, the researchers examined how manufacturers can control the mechanical and physical properties of 3D-printed titanium implants. As an implant material, they claim, titanium is ideal, providing a high level of corrosion resistance due to a protective oxide layer on its surface. In turn, the researchers examined three variables—particle size, temperature and powder compaction level—that play roles in determining an implant’s properties. They showed how adjusting these variables controls the integrity of the finished part.
“Quality control in the manufacture of implants for joint replacement is obviously of the highest concern to surgeons and their patients,” says Mark J. Cola, President and CEO of Sigma Labs, Inc. “Technology now exists that integrates quality control protocols directly into the additive manufacturing process, giving medical manufacturers an unprecedented ability to monitor the quality of their products in real time.”
In 3D metal printing, a component is built up one microscopic layer at a time out of a metallic powder that is manipulated by a laser; a computer-aided design (CAD) blueprint tells the laser exactly how to shape the material—but finalizing that optimal blueprint can be an arduous process.
Sigma Labs has developed a proprietary, patent-protected, quality assurance software suite called PrintRite3D® that transforms the 3D printing process. In contrast to traditional quality assurance that is performed after-the-fact, PrintRite3D works in real-time to assist quality inspectors in sorting acceptable from suspect components.
The PrintRite3D® suite benefits medical device companies that are 3D-printing metal parts in three aspects. The first involves metallurgy: in addition to optimizing the structure/property/parameter qualities of metal parts, Sigma Labs’ software allows engineers to assess each part’s microstructure—scanning and collecting data on potential weaknesses (like “pores” in the metal). The second benefit involves geometry: the software helps capture images of every layer of metal as it is being incorporated into the part; this data, available digitally, gives inspectors the ability to detect any distortion as parts are made and adjust the machine accordingly in real-time. Finally, the software enhances a company’s productivity by collecting Big Data regarding the performance of multiple 3D printers at multiple locations into a single database.
With a core facility in Santa Fe, NM, Sigma Labs offers clients a comprehensive one-stop shop for 3D metal printing and process engineering; alternately, Sigma Labs can offer its suite to clients at their own facilities.
“No patient should ever have to wonder if the part that’s just been implanted within them is structurally and mechanically sound,” adds Cola. “For 3D-printed implants, it is possible that this high quality can be assured.”