Originally Published MDDI December 2004

R&D DIGEST

Navigation Surgery Changing Medical Device Development

Brendan Gill

A new approach to technology-assisted surgery may greatly influence the design of medical devices.

A technique called computer-assisted navigation surgery uses a computer and image-guided camera. It is gaining acceptance as a more precise and less-invasive way to perform surgery. The technology allows surgeons to move an instrument inside a patient's body while its location is displayed on a computer screen. Doctors can guide instruments the way a global positioning system guides drivers to their destinations.

In early trials, navigation surgery has contributed to shorter recovery times and reduced risk of blood clots for thousands of patients. Some in the industry speculate that these positive signs may cause medical device designers to adapt their products to the new practice.

Cameron Georges, director of sales for orthopedics at Brainlab (West-chester, IL), is working with implant manufacturers to make surgical instruments navigation-ready. Brainlab, DePuy (Warsaw, IN), Zimmer Inc. (Warsaw, IN), and Biomet Inc. (Warsaw, IN) are developing medical devices with posts for reference arrays. Reference arrays are small reflective spheres that make it possible for medical instruments to be seen by image-guided surgery cameras.

“Instead of an adapter, we're building navigation components right into the instruments,” Georges says. “Ultimately, this will reduce surgical time and make devices easier to use.”

Because the surgery enables doctors to make smaller incisions, they can't always rely on their eyes to make operating room decisions. David Morrow, director of computer-assisted surgery at DePuy, is developing microchip-embedded implants to improve these circumstances. Called “smart implants,” the devices provide surgical information without the area having to be seen by the surgeon.

“If a patient gets examined every two years, [the microchip] can provide information on whether the implant has sunk or rotated from its position,” Morrow says. “It allows doctors to predict failures of the implant.”

Morrow's team is also developing a detector that can pass over the body to collect information from the implant's microchip. The detector will work “like a security wand at the airport,” he says. Morrow anticipates having prototypes for the implants and the detector in about two years.

Besides surgery, computer-assisted navigation may affect the way other medical devices are used. Navigation systems may replace x-rays and fluoroscopy in the operating room—older technologies that, through years of use, can damage the health of medical personnel. “Cancer is a danger to surgeons; with navigation, the danger is less,” says Mitchell Sheinkop, MD, a professor of orthopedics at Rush University (Chicago).

Sheinkop predicts that in five years a majority of surgeries will be performed with navigation in some form. Sonny Bal, MD, at the University of Missouri–Columbia Health Care, agrees. “This is relevant technology that will ultimately be the standard of care, just like electronic ignition is standard equipment on all cars now,” he says. “Not that long ago, electronic ignition was an expensive optional upgrade, pretty much how computer technology in joint replacement is right now. ”

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