IS THERE A ROBOT IN THE HOUSE?
Its name conjures up images of a futuristic Hollywood cyborg, a coupling of the artificial intelligence of Hal from “2001: A Space Odyssey” and the action-hero physical prowess of “RoboCop.”
But this star robot, dubbed Robodoc, is no smarter than a dumb terminal and resembles nothing as much as a high-tech dental drill. It is in the operating room that Robodoc lives up to its name, displaying a surgical precision that the steadiest-handed surgeon couldn’t match.
Guided by computer instructions, Robodoc is used during hip-replacement surgery to bore precision holes in a patient’s femur, or thighbone--a task surgeons now do manually, using a mallet and chisel, with much less precision.
Marketed in Europe by Sacramento-based Integrated Surgical Systems, Robodoc is to medical robots what the first Apple computers were to microcomputing: first-generation technology likely to spawn increasingly sophisticated offspring.
The medical robot industry “is just starting,” says Russell Taylor, a Johns Hopkins University computer scientist who, along with UC Davis researchers, helped develop Robodoc while he was a robotics research manager at IBM Corp. in the 1980s.
“These machines will be very good at things the surgeon isn’t so good at,” Taylor says. “They’ll combine a machine’s precision with human judgment.”
“The pace has been quite slow, as is the case in most things in health care,” says James C. McGroddy, Integrated Surgical’s chairman and a former head of worldwide research for IBM, which owns 40% of the robot maker. “It’s taken a long time to get the technology to where it is. . . . But this will get to be a big industry.”
McGroddy and other experts say machines like Robodoc--approved for surgical use in Europe but not yet in the United States--are finding a variety of uses in the operating room, such as helping neurosurgeons pinpoint the location of brain tumors, perform biopsies and remove those tumors.
Most of these systems combine workstations, computer-imaging technology and robots to assist surgeons in tasks that are difficult, delicate or demand great precision.
At Johns Hopkins, for example, researchers are studying how a robot may be used to treat liver cancer by more effectively targeting tumors for radiation and chemotherapy treatments.
For now, most of these robotic surgeons are honing their skills in university or hospital research laboratories. But increasingly the research is getting out of the labs and into private industry, where a handful of start-ups are trying to market these devices.
Computer Motion, a Goleta, Calif., firm, has a robotic system called Zeus, which enables surgeons to more easily manipulate instruments with voice commands during minimally invasive surgery known as laparoscopy.
Intuitive Surgical, based in Mountain View, Calif., makes a robotic system designed to help surgeons overcome visual and tactile problems during laparoscopy. An increasingly common procedure, laparoscopy involves inserting thin, camera-equipped tubes into the body through a small incision, allowing the physician to view the patient’s organs during surgery.
But such companies face a host of challenges as they seek to place their technology in surgeons’ hands and in hospitals.
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Some surgeons express concerns that robots will replace them. They also may be reluctant to place patients in the hands of the devices until they become familiar with less-complicated robotic technologies that allow the surgeon to directly manipulate the robots’ actions, researchers say.
“We’re now dealing with more of a learning or comfort curve,” says orthopedic surgeon Anthony DiGioia, co-director of the Center for Medical Robotics and Computer-Assisted Surgery at Carnegie Mellon University in Pittsburgh.
He and other researchers stress that robots are being developed to assist surgeons, not replace them, a distinction that patients also may find comforting.
“People used to say, ‘How do I know the robot won’t go crazy and drill a hole in my brain and not the femur?’ ” says Ramesh Trivedi, Integrated Surgical’s president and chief executive. “I’d say, ‘Well, it has never happened, and there are lots of safety controls built in.’ ”
Adds DiGioia: “When you mention medical robots, people’s image is defined by the entertainment industry--people think of androids or the robots used in manufacturing, which are very different.”
For hospitals, concerns over the cost of new technology--and whether insurers will pay for it--are a key issue. Robodoc, for instance, sports a $635,000 price tag in Europe.
“In the past, the only question for new technology was, did you help the patient, even if it was a small-percentage improvement?” DiGioia notes. “Now a quick follow-up question is, at what cost do these improvements come?”
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Integrated Surgical executives acknowledge those cost concerns but say they have been able to overcome them at several hospitals in Germany and Austria that have purchased Robodoc systems. According to Trivedi, European surgeons working with Robodoc are reporting that hip surgery patients can be released from the hospital four to five days earlier than with conventional methods. That, he says, is because the robotic drilling of the femur results in a tighter fit of the implant and less trauma to the bone and allows the patient’s leg to bear weight sooner.
Moreover, some European hospitals are using Robodoc as a marketing tool to enhance their reputation as state-of-the-art centers for hip surgery, hoping to boost patient volume. One Frankfurt hospital reports a nine-month waiting list for the Robodoc procedure, Trivedi says.
Hip surgery was an obvious choice for medical researchers exploring the use of robots because of the physically laborious nature of the surgery.
The surgeons manually carve a cavity in the patient’s thighbone, a process that has been compared to carpentry, Trivedi notes: “You literally hear this bang, bang in the operating room.”
Like crude woodwork, the process results in a very rough fit. Surgeons usually get around this problem by using cement to hold the implant in place. But the cement loses its grip in five to 10 years, forcing many patients to undergo one or more replacement surgeries.
With Robodoc, the most suitable implant--and the exact size of the bone cavity needed to fit that implant--is predetermined with the aid of computer imaging. After Robodoc bores a hole in the bone, the implant fits to within a tenth of a millimeter, Trivedi says.
Robodoc was developed by Dr. William Bargar, a Sacramento orthopedist, and the late Hap Paul, a UC Davis orthopedic veterinarian who used an early version of Robodoc on dogs with hip ailments.
The company, which raised $6.1 million in a public stock offering in November, plans to file for Food and Drug Administration marketing approval later this year.
The company has sold eight Robodoc systems in Europe since marketing began there in 1996. Growth has been slower than then-company executives had predicted four years ago, when they forecast sales of “several hundred” Robodocs by 1996.
Still, the market potential remains huge: Surgeons perform about 550,000 hip replacements annually worldwide, roughly half of them in the United States, where the surgeries cost about $15,000. The orthopedic supplies market is estimated at about $8.9 billion worldwide.
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Company executives say Robodoc could be adapted to perform so-called hip revision surgery, a somewhat more complicated operation that involves removing a worn-out hip implant and cement fragments and replacing the implant. Another potential use is knee-replacement surgery, another multibillion-dollar market.
For now, the company’s main competitor is the old manual surgery method. But Maquet, a German medical equipment maker, recently announced plans to begin marketing a product similar to Robodoc in mid-1998.
With any luck, the German firm won’t name its product Robodoc II.
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Mechanical MD
Robodoc, developed by Sacramento-based Integrated Surgical Systems, is being used by orthopedic surgeons in Europe to assist with hip-replacement surgery. The company is seeking approval from the U.S. Food and Drug Administration to market the device in this country. A brief look at how physicians use Robodoc.
1. The surgeon takes a three-dimensional CT scan of the patient’s femur, the large bone running from the hip to the knee.
2. The surgeon transfers the image to Integrated Surgical’s computer workstation.
3. While viewing the 3-D image, the physician chooses the correct hip implant for the patient from a variety of implants stored in the computer’s memory.
4. The digital information about the patient’s hip and the implant is stored in the workstation.
5. In the operating room, the surgeon exposed the patient’s femur. The computer relays detailed instructions to the robot about the size, shape and location of the implant cavity.
6. Robodoc precisely drills a cavity into the patient’s bone. The surgeon retains full control of the robot’s operation, using a remote-controlled device with a “stop” button. When the robot is finished shaping the cavity about 20 minutes later, the surgeon fits the implant and completes the 90-minute surgery.
Source: Integrated Surgical System.
