For much of its brief history, robot-assisted surgery has been synonymous with Intuitive Surgical, Inc.’s da Vinci system. It’s the only robot with U.S. Food and Drug Administration (FDA) approval to help surgeons perform a number of laparoscopic soft-tissue procedures, including hysterectomies, gall bladder and kidney removals, prostate cancer treatment and heart valve operations. Da Vinci has improved vastly since Intuitive introduced it more than a decade ago. Like many new technologies, however, it has experienced growing pains, leading some engineers and medical professionals to question whether a single company can meet growing demand while still delivering a safe product.
A team of researchers is looking to address these issues by developing a robotic surgery system based on hardware designs and software that are freely available. In this open-source approach, the builders would keep whatever intellectual property they’ve invested in the project but must make their knowledge and discoveries available to others.
The researchers, from the University of California, Santa Cruz, and the University of Washington (U.W.), hope their efforts will lead to a number of advances in surgical-robot technology that would stem from a basic design that wouldn’t change from device to device. The idea is that the costs of building—and buying—multimillion-dollar robotic surgery systems would decrease, as would the learning curve to use them.
The open-source model has worked well in the software industry, enabling startup companies to challenge Goliaths like Microsoft and Oracle by offering lower prices as well as collective review of new advances. Some of the more visible products of open-source innovation include Google’s mobile Android operating system, which is based on Linux, and Mozilla’s Firebox Web browser. Engineers and designers have also launched efforts to collaboratively develop open-source general-purpose robots as well as prosthetic limbs. Brewers have even applied the approach to making beer, tweaking and redistributing one original recipe to a broader community of enthusiasts.
Da Vinci has been assisting surgeons since it received FDA approval in 2000, helping them operate quickly and efficiently in tight spaces. The device’s four arms can wield any number of instruments, including scalpels, forceps, graspers and scissors to, for example, make incisions, remove organs, place catheters and close incision points. A surgeon controls these tools while sitting comfortably in front of an ergonomically designed console with the aid of a high-definition 3-D camera, reducing concerns about fatigue during long procedures. Despite its nearly $2-million price tag, the da Vinci’s popularity has grown steadily in recent years. In 2012 doctors used the system to perform more than 350,000 surgeries in U.S. hospitals, a 60 percent increase from 2010.
Intuitive designed the da Vinci to improve on existing laparoscopic surgery—also referred to as minimally invasive surgery because the surgeons perform most of the repair work inside the body by passing tiny video cameras and tools through small incisions. Physicians have reported several advantages to using da Vinci, including less patient bleeding and shorter surgery times, both of which lead to reduced hospital stays and recovery times. T. Sloane Guy, chief of robotics and section chief of cardiovascular surgery at Temple University School of Medicine, likens conventional laparoscopic tools to “chop sticks” and says da Vinci’s computer-controlled tools provide greater freedom of movement in snug spaces during surgery.
Despite advantages, adverse reports related to these surgeries have grown along with their use. The FDA received 3,697 adverse reports from Intuitive and hospitals using the system that involve deaths, injuries or malfunctions linked to robotic surgery procedures from January through November 2013, compared with 1,595 in all of 2012. The agency has acknowledged that there are likely many more events that go unreported, and patients have begun to file lawsuits against both Intuitive and hospitals following complications during procedures in which da Vinci was used.
A small group of surgeons shed some light on problems with da Vinci in an FDA study published in November. (pdf) These included a crack in a robot arm that caused an instrument to fail, an arm that drifted during a procedure and collisions between arms during surgery. No injuries to patients were reported as a result of these specific incidents, but the study provides insight into da Vinci’s successes and failures as well as the training required to use the system. The FDA cautions, however, that this report is in no way comprehensive—it includes feedback from only 11 surgeons, although each performed 70 to 600 surgeries using da Vinci over the last three years.
The researchers from U.C. Santa Cruz and U.W. have been developing iterations of their robot—called the Raven—for more than a decade. Thus far they’ve shipped 14 Raven II robots to universities in the U.S., Canada and France, including Harvard University, Johns Hopkins University, the University of Nebraska–Lincoln, University of Montpellier and the University of Western Ontario. Each of these systems has a unique Internet Protocol (IP) address and has been networked to the others, to create a common platform through which the researchers can share software, replicate experiments and collaborate in various ways.