Editor’s note: This article was provided by Medtech SA staff.
A particular approach to brain surgery once required a lengthy procedure that kept a patient under anesthesia for several hours. A robot assistant now cuts that time in half.
To treat drug-resistant epilepsy, surgeons sometimes use stereoelectroencephalography, or sEEG, a surgical procedure that identifies areas of the brain where epileptic seizures originate. The procedure, a precursor to surgical intervention for epilepsy, involve inserting depth electrodes in targeted brain areas that doctors monitor to locate the source of a seizure. When doctors find the source, surgical resection and a positive outcome may be possible.
Fortunately, sEEG enables a more accurate diagnosis of epileptogenic zones with fewer complications than other options, such as the placement of subdural grids for exploration. However, the traditional stereotactic-frame approach requires complicated surgery that keeps the patient under anesthesia for several hours.
Medtech founder and CEO Bertin Nahum and his team have created an integrated solution for sEEG by developing a robot for brain surgery called ROSA. The robot helps the surgeon place electrodes more accurately and efficiently, reducing the time it takes to complete an sEEG procedure thereby minimizing patient discomfort.
The key to ROSA’s efficiency is a patented registration system combining precise robotic movement with non-invasive laser measurement. With this method, the intervention can be performed without the use of invasive markers or frames.
Before ROSA, Nahum worked for his undergraduate degree in electrical engineering from the National Institute of Applied Sciences in Lyon, France. He says that his vocation became clear while he was in school.
“At the end of my course, I participated in designing software that could detect cranial lesions with scanners,” Nahum said. “This feeling of usefulness made me want to devote my career to patients, but from the technicians’ side, by designing robots that would be capable of helping surgeons during operations.”
Nahum continued his education at Coventry University in the U.K., where he earned an Master of Science degree in robotics. He spent nearly a decade honing his skills by working in surgical robotics for companies such as Computer Motion, Integrated Surgical Systems and IMMI SA. In 2002, Nahum founded Medtech with four collaborators.
The first robot Nahum designed, BRIGIT, was for knee surgery. Nahum and his colleagues designed, developed and eventually shepherded the device through to CE marking and FDA approval. In 2006, Zimmer, a manufacturer of orthopedic prostheses, bought the entire portfolio of patents for BRIGIT.
Medtech reinvested the money from BRIGIT to design the more sophisticated, next-generation ROSA in 2009. This later robot has gained endorsements from surgeons worldwide for its precision and is both CE marked and FDA approved.
“Frameless stereotactic procedures can be performed safely and effectively with ROSA, reducing operating times and eliminating radiation exposure,” said Dr. Olivier Delalande, a surgeon at Ospedale Bambino Jesu in Rome.
The robot is currently installed and in use at 48 hospitals worldwide, including 19 hospitals in the U.S. at leading institutions such as Emory University and Texas Children’s Hospital. It has participated in more than 2,300 interventions. With traditional techniques it would never have been possible to treat such a large volume of patients. Of the various types of procedure with which ROSA has assisted, 45% have been sEEG procedures.
In the sEEG procedure, the combination of the optical-distance sensor and robotic system allow a fully frameless approach in three simple stages. First, the surgeon inputs the required implantation trajectories on preoperative 3D MR acquisitions using ROSA’s dedicated software. Then, the team brings the system into the O.R. for registration. Finally, the robot automatically positions an instrument on the pre-planned trajectory. The surgeon may then drill his access point and implant the electrodes through the instrument holder.
During surgery, the robot’s instrument guidance enables fast and accurate electrode implantation. The robot moves from one trajectory to the other in a matter of seconds, so that procedures now last one-and-a-half to three hours rather than the six hours it can take for the same procedure using a frame-based approach.
In addition to Medtech’s patented guidance system, ROSA has a robotic arm that replicates the movements of a human arm with six degrees of freedom. The device provides high dexterity for complex surgical procedures and the surgeon has complete freedom in the choice of trajectory.
ROSA offers neurosurgeons the added possibility of guiding their instruments by hand, within the limits established during the planning stage, prior to surgery. The surgeon easily interacts with the robot without changing any of his surgical techniques, gaining the benefits of robotic movement.
According to Dr. Jorge Gonzalez of the Cleveland Clinic, the robot has the potential to increase the “safety and feasibility” of sEEG procedures.
Furthermore, the robot provides a stable, sturdy support for optimal drilling and electrode implantation. The instrument guide’s position may be adjusted along the trajectory using ROSA’s haptic manipulation mode. This technique lets the surgeon set the guides at the correct drilling distance by hand, while ensuring that the instrument remains aligned with the planned trajectory.
“ROSA is remarkable for its extreme precision and surprising adaptability to different neurosurgical gestures,” said Dr. Michel Lefranc of the University of Hospital Amiens-Picardie in France.
Although ROSA has been integral in treating epilepsy, the technology’s inherent flexibility lends itself to a broad range of surgical applications. These interventions include biopsies, electrode implantation for functional procedures (stimulation of the cerebral cortex, deep brain stimulation), open skull surgical procedures using navigation, ventricular and transnasal endoscopy and other keyhole procedures.
For example, Medtech recently announced that UC Irvine Medical Center neurosurgeon Dr. Frank Hsu completed the first deep brain stimulation surgery for a 56-year-old Parkinson’s disease patient using Nahum’s robot. Dr. Hsu used it to implant electrodes in the patient’s brain for deep brain stimulation, thus disabling the overactive nerve cells that exacerbate Parkinson’s symptoms.
While they continue to focus on advancing ROSA in the U.S. and abroad, Nahum and his Medtech team are also driving the adoption for the recently developed ROSA Spine, which was CE marked in 2014. Medtech expects FDA approval for use of the device in the United States in 2015.