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Lasers in Medical Manufacturing


other medical professionals are looking for medical technology that can reduce or eliminate these problems. Bioresorbable stents may just be the solution, but there’s no definitive answer because researchers are still testing them in humans. While medical professionals design and test new kinds of stents in people—whether permanent implants or biore- sorbables—laser makers are working to improve technology for making both types. “All the manufacturers of lasers that are going into industrial and medical applications, they’re all touting stents,” said Michelle Stock, president of mlstock con- sulting in Ann Arbor, MI. “Truly where the impact will come is when we get to the newer materials.”


in the fallopian tubes, the bladder and kidneys, the esopha- gus, the gut, the sinuses, the arm (for hemodialysis access), and more. Different body sites call for different designs, sizes and materials. For example, while the protected area near the heart doesn’t need nitinol’s shape-retention properties, a leg stent that is subject to everyday wear-and-tear does. As the need for stents grows, so does the money to be made from designing and manufacturing them. According to ABMRG (Bristol, TN), a global authority on medical technology market intelligence, the global market for coronary stents alone is expected to top $13 billion by 2019. “Small to medium-size companies from the developing economies are ambitiously conducting clinical studies to win the approvals and expand the use of devices for new indica- tions,” said Tammy Thomas, ABMRG’s lead pipeline analyst. Although small to medium companies may be frantically working on bringing new stents to market, Abbott Laboratories (Abbott Park, IL), Medtronic (Minneapolis) and Boston Sci- entific (Natick, MA) already dominate the increasingly global business. These three lead the global stent market, whether permanent or bioresorbable.


And even as medical device manufacturers continue producing metal stents, it appears that they are turning toward bioresorbables as their Holy Grail.


TRUMPF Inc. said the green wavelength is best for cutting stents such as this.


That’s because there are so many uses for stents, and because there’s an unmet need for unusual configurations and smaller sizes.


How Small Can They Get? Sascha Weiler, program manager for micro processing at TRUMPF Inc. (Farmington, CT), said that while it’s possible to cut a kerf 10–12 microns wide with good cutting quality, it’s impossible to get the waste material out of a space that small. “The cutting kerfs are so narrow that the material won’t fall out,” he said. “With the laser you could focus down even tighter, but it doesn't give you any advantages.” Blood vessels are the most common sites for stents, whether near the heart, in the carotid artery in the neck, or in a peripheral location such as the leg. But stents are also used


100 ManufacturingEngineeringMedia.com | May 2014


“The interest in reabsorbable stents is increasing,” said Dan Capp, vice president of sales development for Laserage, a job shop in Waukegan, IL, with 40 laser systems working on all types of devices. “Everybody is making them, from the three-man little companies to the big monsters.” Absorbable stents have become so ubiquitous that in 2013 worldwide standards organization ASTM International (West Conschohocken, PA) established a new standard for testing them that addresses changes in their physical and mechani- cal properties, such as radial strength from initial manufacture to final degradation in the body. ASTM F3036, Guide for Test- ing Absorbable Stents, addresses pretest conditioning require- ments, handling requirements before and during the test, and time-dependent mechanical property evaluations.


Metals


Despite the buzz over bioresorbables, manufacturers are still using lasers to make metal stents and doctors are still implanting them. Lasers work so well in the industry because they produce clean edges that reduce or eliminate the need for postprocessing. They also do away with the need for tool-


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