Volume 17 Number 3 FALL 2000

Great Inventions Don’t Happen Overnight

DEVELOPMENT OF
THE FOGARTY
BALLOON CATHETER

THE FOGARTY BALLOON CATHETER SEEMS SO SIMPLE -- A SLENDER TUBE WITH AN INFLATABLE BALLOON AT ITS FAR END -- THAT YOU MIGHT ASSUME THOMAS FOGARTY, MD, INVENTED IT OVERNIGHT. Far from it. Like most worthwhile inventions, it was a years-long work-in-progress. The seeds were planted when Fogarty was in high school working as a scrub technician at Good Samaritan Hospital in Cincinnati. He had started working at the hospital in the eighth grade in the late 1940s, cleaning medical equipment to help his widowed mother make ends meet.

* "While working as a scrub technician, I saw lots of patients suffer, lose limbs or die from cumbersome surgery to remove blood clots from their arteries," says Fogarty, a Stanford professor of surgery. "I began thinking that there must be a better way of doing this. But it didn't come to me for a long time -- many years, in fact. I made a balloon catheter in medical school, but didn't have a chance to try it out until my fellowship year."

* The tool he designed works like this: The surgeon inserts the catheter downstream from the clot through a small incision in the clogged artery and threads the catheter up the artery and through the clot. Once past the clot, the surgeon inflates the balloon at the catheter's tip and pulls the catheter back, withdrawing the clot through the artery and then out the incision.

* "Fogarty's catheter, the first minimally invasive surgical device, was based on a seminal idea: that we didn't have to cut a wide trough in a patient to do the job," says Paul Yock, MD, Stanford professor of medicine and director of the Stanford Medical Device Network. "Previously, the mind-set was 'make as big a hole as possible so that the surgeon can see and work.' "

* Fogarty developed the balloon catheter at home between study sessions for medical school. In his attic, he tinkered repeatedly with a urethral catheter and the tip of a rubber glove, using basic fly-tying techniques he had learned as a boy. One recurring problem was that his experimental balloons often broke -- popping when he accidentally overinflated them or rupturing when he dragged them through the narrow tube he used to simulate an artery. After several years, he figured out the type and thickness of rubber that was stiff enough when inflated to extract a clot, yet flexible enough to move through a narrow opening without tearing.

* But the challenges didn't stop after he developed a workable device. "I couldn't get any manufacturer to make the catheters,"explains Fogarty. "Companies thought I was some stooge fooling around. I didn't have any credibility." Disappointed but undaunted, he made the catheters by hand for himself and other vascular surgeons during his fellowship training at the University of Cincinnati in 1961 and 1962. (Fogarty was allowed to complete a fellowship before residency because of his unusual circumstances: He was waiting in Cincinnati to be inducted into the military. In the end, the military never did call him for duty.)

* Later, at the University of Oregon, while Fogarty was completing a residency in surgery, Al Starr, MD, head of the cardiothoracic division, used Fogarty's catheters with great success. After discovering that no company would manufacture Fogarty's catheter, and convinced that the catheter was a great leap forward, Starr asked an acquaintance, Lowell Edwards, an electrical engineer and president of his own company, to consider producing it. In 1963, Edwards saw the device in action and immediately began manufacturing the Fogarty embolectomy catheter. It quickly became the industry standard because it was easier on both the surgeon and patient.

* Now marketed by Edwards Lifesciences (Irvine, Calif.) as the Fogarty® balloon catheter, Fogarty's device is estimated to have saved the lives and limbs of approximately 15 million patients.

CHRISTIE RIGGINS

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