Thomas Fogarty was a 19-year-old scrub technician at Good Samaritan Hospital in Cincinnati when he came up with a seemingly simple notion that would eventually lead to one of the most dramatic changes ever in the treatment of cardiovascular disease.
Working in his attic, the inventive teenager snipped off the fingertip of a latex surgical glove and used a fisherman's fly-tying technique to attach it to a catheter--thus creating what eventually became known as the Fogarty catheter. It marked the beginning of noninvasive surgical procedures that have saved hundreds of thousands of lives around the world since 1961.
Fogarty, now a 70-year-old cardiovascular surgeon who says he holds about 120 patents ("I don't count 'em," he says), is one of the best-known and most successful physician inventors in the nation. His most noted invention--known as the Fogarty balloon embolectomy catheter--sprang from a basic observation that there must be a better way to care for blockages in arteries and veins. From that idea, he developed a method of modifying a catheter with a small, inflatable balloon that could be inserted into the patient through a small incision to remove the clot in a blocked artery.
"I was in medical school when I came up with the concept," says Fogarty, a professor at Stanford University School of Medicine. "But the key is just making the observation of what works and what doesn't work. Then, if you recognize something that doesn't work, you've got to try to resolve it. Most people don't follow through--they never try to implement changes. I can't tell you how many people say, 'Oh, I thought about that' (in discussions about various inventions). But how many actually do it? And unless you make something that's functional, the thought is useless."
First used in 1961
The first procedure with Fogarty's balloon embeloctomy device was performed in 1961. A patent--No. 435,826--was issued in 1963. The rest is history. His catheter is now used in hundreds of thousands of procedures every year. It also has helped propel numerous advances in other minimally invasive procedures, including angioplasty.
In honor of his inventions, Fogarty in 2000 won the prestigious Lemelson-Massachusetts Institute of Technology Prize, which includes a $500,000 cash award, the largest for inventions. At the time, William Brody, president of Johns Hopkins University, said Fogarty had "single-handedly changed the face of cardiovascular surgery."
Paul Gianneschi, an Atlanta lawyer who works with doctors who are inventors, described Fogarty as the "granddaddy of all physician inventors."
The busy Fogarty, who attended the University of Cincinnati College of Medicine, has founded or co-founded more than two dozen companies that produce devices based on his patents. He also established Three Arch Partners, a venture-capital firm that sponsors Stanford's support group for inventors, Medical Device Network, and helps raise funds for young inventors.
That firm, Fogarty says, has helped support inventions leading to "well over 1,000 patents," including one device, the Revivant AutoPulse, that does automatic closed-chest massage instead of manual CPR. While manual heart massage generates about 15% to 20% of the cardiac output for the first 10 minutes after a heart attack before output begins deteriorating, this new technology will deliver anywhere from 60% to 70% of cardiac output, Fogarty says.
"If you want to look at something that's going to result in a major paradigm shift, this is it," Fogarty says. "This is going to make a major change in the way we resuscitate."
Fogarty's venture-capital company, he adds, also is instrumental in helping inventors navigate the increasingly complex regulatory and legal maze that has made the patent process far more difficult than it was in the early 1960s. "The difficulty, compared to 1960, is probably 1,000-to-1," he says. "There's federal and state regulations, reimbursement issues, clinical acceptance, teaching and training. The whole thing has gotten extremely complex and arduous."
The guillotine to Esperanto
Physicians--smart, inquisitive, well-schooled in the sciences--have always been among the world's most prolific inventors. Their inventions include the guillotine, the percolator, the Rorschach inkblot test and the international language of Esperanto. Of course, physicians also have developed penicillin and the polio vaccine, to name just two medications.
Are doctors better equipped intellectually to tinker with innovative new ideas? While nearly one-quarter of the roughly 220 individuals in the National Inventors Hall of Fame are doctors, Fogarty, for one, doesn't think physicians are naturally creative or ingenious.
"Look at the way physicians are trained," says Fogarty, whose imaginative streak is not limited to medical devices--he founded Thomas Fogarty Winery outside of San Francisco in 1991. "They're trained to do the same thing the same way all the time. They really don't have time to challenge or reflect on options or alternatives, because they're required to assimilate so much knowledge in such a short period of time. Also, if they deviate from standards, they are subject to great criticism from their peers and also from the medical-legal profession.
"That stifles innovation. Physicians who invent have a different mind-set. They go into every operation saying, 'I can do this better than I did the last time.' Not only better the same way, but to try with a different approach."
So what, exactly, does it take to be a physician and an inventor? "You've got to be a deviant," Fogarty says.
Solving a needling question
In many ways, Mitchell Dombrowski, 51, is very much like Fogarty. He is a creative, imaginative physician who saw a need--in this case, the prevention of needlestick injuries--and devised a way to deal with the problem.
Dombrowski, an OB/GYN in Detroit who is a professor at Wayne State University, began mulling over the need for some type of a safer, self-capping needle in the late 1980s, a time when hepatitis B was endangering many healthcare workers and AIDS and HIV were presenting a growing worry.
Back then, healthcare workers simply placed a cap on disposable needles, placed them in puncture-resistant containers or used a needle guard that didn't completely cover the tip, Dombrowski says. He thought there was a better way--capping the needle from the base up, to further minimize the risk of injury. His invention--the idea struck him while he was sick with a fever--allows doctors and nurses to remove an intravenous needle in a single motion.
"There was always a danger in capping the traditional way," he says. "I thought, 'How about from the base up?' The trickiest thing about inventions is coming up with an idea that is simple. The trick with this invention was to make it simpler and simpler and simpler so you got it to the point where people say it's obvious. And that's the best invention there is."
The needle has a small cap that rests near the base, or hub, and is connected to a tether that keeps it from falling off the tip. The first commercial design was self-capping butterfly needles. The second design was adapted for IV needles. Dombrowski says "millions and millions" of these needles have been used around the world since the device was patented in December 1988.
Dombrowski says he and his business partner, Robert Welch, sold the patent to Johnson & Johnson in 1991, then finally sold all rights to the self-capping needle about two years ago. He won't say exactly how much he made as a result of the invention, only saying, "We did very well."
Ironically, he recalls, Johnson & Johnson was working on its own version of a self-capping needle, but negotiated with Dombrowski after the company discovered that their design infringed on the existing patent. "There was a flurry of people who applied for patents in the late 1980s (for self-capping needles)," he says. "In some cases, we beat them by just a few months."
Together, Dombrowski and Welch had invested about $50,000 of their own money to develop the self-capping needle, which was eventually marketed as Angel Wings and won a national award for design excellence.
"You have to have faith in your own idea," he says. "We were able to recoup our investment handsomely. But our basic motivation was that we had a good idea and that it could save lives."
For his part, Dombrowski has turned inventing into far more than just a sideline. He holds about a dozen patents, including one on a fetal blood-sampling instrument and another for cut-resistant surgical gloves.
Dombrowski, who is chairman of the department of obstetrics and gynecology at St. John Hospital and Medical Center in Detroit, differs from his inventor-colleague Fogarty on one important point: He thinks physicians, because of their training and background in science, are perfectly suited for the kind of creative thought that comes up with the ideas for self-capping needles and balloon catheters.
"Physicians, on the whole, tend to be relatively smart," Dombrowski says. "I think that those smarts, a scientific background and the fact that we are taught to be logical all play a role. And you're often placed in a situation where you use high-tech equipment. You're always trying to advance medical technology. You're in a position to see a need. I saw that need in the late 1980s."
Fastest clip in the West
Charles Klieman, a cardiovascular surgeon in Lynwood, Calif., remembers growing frustrated years ago at the time and effort--not to mention dexterity--required to individually clip blood vessels on the operating table.
In the 1980s, he designed and patented an instrument with a cartridge of these clips. In use since the late 1980s, they have been marketed by Ethicon Endo-Surgery, a Johnson & Johnson subsidiary.
"I was getting frustrated handling just one clip at a time during surgery," says Klieman, former president of the American College of Physician Inventors, which is no longer active. "Instead of having to clamp (a blood vessel) and tie it with sutures, you use this clip. It just occurred to me that we have to develop a system of cartridge clips. So I designed it, worked on various iterations and invested money in it. Actually, in order to be successful, you need several things: You need to have patience. You must be focused. You need to invest some money. And you need a good patent attorney."
After developing his own design, Klieman says he brought several engineers on board to help build a prototype, a process that took a couple of years to work through the problems.
Among the stumbling blocks: "In the clip design and cartridge design, we had to build the most perfect clips in the world because you're stacking them (on top of one another)."
The clip applicator is a cartridge that delivers the titanium clips in rapid-fire motion, similar to a stapler, Klieman says. His invention is marketed by Ethicon as the Ligaclip Multiple Clip Applier, described on Ethicon's Web site as a "sterile, disposable automatic ligating clip applier" that can be loaded with 20 or 30 clips that automatically advance.
"The technology is extremely complex, but it's in a simple package," Klieman says. "Like most inventions, it's best to simplify complex things."
In his patent application, Klieman broke down his brainstorm in simple terms that almost any layman could understand.
"In a typical surgery procedure, a great many veins, arteries and other blood vessels must be severed and closed," his patent application states.
"This is often a difficult and time-consuming procedure since many vessels are located in obscure areas where there is little room in which to work. Thus, it is apparent that a device which would reduce the time required for closure of blood vessels would be a great benefit to both the surgeon and the patient."
Klieman says the need for a clip for surgical staples was so obvious that several other inventors and companies were working on similar ideas. He just happened to come up with it first.
"I think it was thought of before me--the invention wasn't perfected, though," he says. "I was fortunate to figure it all out before the others did. It was something that was needed. And when you come up with any idea, you've got to figure that somebody else has thought of it, too. You know that if it's obvious to you, it's also obvious to 10 other people.
"The key is getting that idea patented, designed and manufactured."
For about a year or so after receiving his patent, Klieman says, he manufactured the clip mechanism himself. He eventually licensed the patent to Johnson & Johnson. Millions of these clips in cartridges have been used over the years in surgeries around the world, Klieman says.
Since inventing the surgical-clip applicator, Klieman has received about 15 patents, including a laparoscopic instrument that articulates, allowing surgeons to use them at different angles. One instrument is being manufactured and marketed by ConMed Corp., a medical technology firm. Klieman also developed software that provides surgeons with a good view on how the instruments work.
He says he's one of a breed of surgeons who see something wrong and try to correct it. "Surgeons are people who actually do something within the body," he says. "Sometimes, we run into problems. It's a little like riding in your car and it's not running right. You ask, 'How can I fix this?' It's the same thing when you're working inside the human body. You're asking, 'How can I make this procedure better, or how can I accomplish this task more effectively?' "
Klieman, a physician since 1974 who still practices and still "loves to do surgery," won't say how much he invested in his invention or what the financial payoff has been.
"I was pleased with what it provided me," Klieman says. "It's been a success. And it makes me very happy that I was able to provide this contribution to surgery."
Building a better toothbrush
As a resident in pediatrics in the early 1990s, Ari Silver-Isenstadt's thoughts were on less-momentous ideas than creating revolutionary new catheters or devising a rapid-fire way to clamp blood vessels during a delicate surgery.
His deepest musings were focused on children's hygiene--or, more specifically, on devising some sort of a plan to encourage children to brush their teeth twice a day.
For whatever reason, that pragmatic objective sprung to mind while Silver-Isenstadt was on a camping trip in Sequoia National Park in California with his wife, Jean.
"We were talking about what motivates kids to brush their teeth--and this was before we even had any of our own," says Silver-Isenstadt, 35, a pediatrician practicing in Baltimore. "Of course, there's nothing new in the fact that it's always been tough to get kids to brush their teeth.
"They need some motivation. Or a reward. I knew that in a lot of emergency rooms and doctors' offices, when you give kids shots, you give them stickers afterward. For whatever reason, they love it. They're just an incredibly motivating tool. And that gave me an idea."
So Silver-Isenstadt and his wife, brain-storming among the towering trees in California's oldest national park, conjured up the idea of a toothbrush that rewards kids with a bright, multicolored sticker every time they brush their teeth. After working through a series of designs on the sticker-dispensing toothbrush, he received a patent in 1999--almost two years after filing his application.
Since he hatched his idea in the early 1990s, kids' toothbrushes have evolved to the point where many of them are almost like toys--complete with handles resembling cartoon characters or blinking lights, among other characteristics aimed at getting the attention of children. Some of the newer packages, meanwhile, include brightly colored stickers. Yet none contains the key feature that sets Silver-Isenstadt's design apart--a roll of stickers, contained inside a handle about the size of a large electric toothbrush, that dispenses one decal for every brushing.
Parents use a special key to turn a secure crank on the bottom of the handle, rewarding the child after each brushing with a waterproof sticker that is bound to others like a roll of stamps inside the handle.
He thinks there's a wealth of potential co-branding opportunities with companies like the Walt Disney Co., Pixar Animation Studio and any number of comic-book characters.
"The roll of stickers can include any image--say, Shrek, Disney, television tie-ins. Remember, this is all a fantasy--we could feature horses on the stickers, or cars, jets, sports teams, dinosaurs. Name a topic. It can be featured on the stickers."
Still just a concept
At this point, the toothbrush is more of a concept than a fact. After spending at least $40,000 on his pet invention, he says, he continues his quest for a partnership with a company willing to manufacture and market the toothbrush.
About the time Silver-Isenstadt was awarded the patent, he formed his own company, called Inno-Vent, and sold a piece of it to five family members and one of his professors in medical school. Even before developing the first design for the toothbrush, he hired an animator to create a "virtual prototype" as a way to help sell it to manufacturers.
He says he even arranged a meeting with representatives of Johnson & Johnson, pitching the idea at a coffeehouse in New Jersey in the summer of 2000. "They liked it--they thought it was a great idea," he recalled. "But they ran the numbers and felt like for them it wouldn't be enough of a markup to be worth their investment."
Still, despite setbacks over more than a dozen years, Silver-Isenstadt remains optimistic that his idea is a winner.
"Parents are spending a tremendous amount of money on dental hygiene for their kids--look at all the electric toothbrushes that are being sold these days," he says. "It's already proven that people will spend a lot of money on cleaning their teeth. I'm absolutely convinced that stickers are a strong motivational tool."
He adds, "Come back and talk to me in 10 years, when it's a huge success."
Of course, if worse comes to worse, Silver-Isenstadt and his wife can always use the prototype as a motivational tool for their own kids--now ages 8, 6 and 2.
"They keep asking me when my toothbrush is coming out," Silver-Isenstadt says with a laugh.