Virtual Incision's robotically assisted surgical device is inserted completely into the body to perform colon resection.
In the medical profession, you have generalists and specialists. So too, with robots. Although the generalists--most notably Intuitive Surgical's da Vinci systems--perform the bulk of robotic surgery, procedure-specific systems show promise in areas the require micrometer precision, such as ENT microsurgery, cochlear ear implantation, MRI-guided biopsy, and vitreoretinal eye surgery.
According to an ECRI Institute survey, surgeons performed 570,000 da Vinci procedures worldwide in 2014 alone, most of these (79%) in the United States. However, the systems range from an average quoted price (according to ECRI Institute) of $1.79 million for a da Vinci Si to $2.31 million for a da Vinci Xi dual console. Add in clinician training and machine servicing, and you've got a major investment decision for budget-conscious hospitals.
Specialized robots have the potential to provide a cost-effective solution. Most products in development are a fraction of da Vinci's size, which makes them easier to operate and move between operating rooms. And most come in at less than half the cost.
Smaller components and snake-like instruments give some specialist robots the ability to perform feats not possible before. Medrobotics recently received FDA clearance for its Flex® Robotic System, a shapeable, steerable device, to be used in colorectal procedures. Flex is the first robotic surgical platform to offer ScarfreeTM access to hard-to-reach anatomy in otolaryngology and colorectal procedures.
In September 2016, Robert MacLaren, University of Oxford Professor of Ophthalmology, assisted by Dr. Thomas Edwards, a Nuffield Medical Fellow, used a remote-controlled robot developed by Preceyes BV, a Dutch medical robotics firm, to perform the first-ever robot-assisted eye surgery.
During the retinal surgery, surgeons lifted a membrane 0.01 millimeter thick from the retina at the back of the eye. "Imagine trying to do that with a manual instrument," said Dr. Rob Morgan, vice president, medical for global product development company Sagentia. "The use of robots in eye surgery has opened up new possibilities."
|A robot at the University Hospitals Leuven is used to perform retinal vein occlusion surgery.|
In January, eye surgeons at University Hospitals Leuven, in Belgium, became the first to use a procedure-specific robot to perform retinal vein occlusion surgery. Treatment for this condition, which can cause blindness, is currently limited to injections that only reduce side effects. The robot-assisted procedure addresses and treats the cause, a blood clot in a retinal vein.
To dissolve the clot, the surgeon uses a needle that's about 0.03 millimeters in diameter to inject medicine into the vein--which is only 0.1 millimeter wide. "Retinal vein catheterization requires tremor-free microneedle placement for a period of 10 minutes, which is only possible with a specialized robot," said Morgan.
Because robotics hold such promise in eye surgery, Cambridge Consultants developed Axsis, a soda can-sized robot that makes the microscale movements needed for procedures such as cataract surgery. The device uses flexible instruments 1.8 millimeters in diameter. This eliminates the need for large ranges of motion outside the body.
In addition to using articulating instruments, Axsis bases its instruments on a parallel mechanism, which uses several chains to control a single platform. "No motor carries the weight of any other motor," said Chris Wagner, head of Advanced Surgical Systems for Cambridge Consultants. "That means our motors can be a lot smaller. We use a transmission element to connect the motion of the motors to the articulation at the tip of the instrument."
Cataract surgery already has a success rate of 98% or higher, but if a robot, with its tremor reduction and minimally invasive access, could reduce the complication rate by another percent or more, those improved patient outcomes could make the investment worthwhile, especially as health systems adopt value-based care models.
One company with potential to bring a product to market in the near future, Virtual Incision, completed successful in-human use of its miniature robotically assisted surgical device (RASD) in 2016. RASD specializes in colon resection, a procedure used to treat patients with colon polyps, cancerous and precancerous lesions, Crohn's, and other gastrointestinal diseases. The company is currently working toward FDA 501(k) clearance.
RASD works differently than most, as surgeons insert the entire device into the body through a single abdominal incision. Virtual Incision expects the device to be less expensive and more portable than existing laparoscopic surgery robots, which may make it a more feasible investment for some hospital systems.
About two-thirds of colon resection procedures are performed via open surgery, which involves an eight- to 12-inch incision, and up to six weeks of recovery time. RASD promises to change that.
"If you can remove three to eight days of hospital stay and associated costs, per surgery, the hospital benefits," said Virtual Incision cofounder and chief technology officer Shane Farritor, PhD. "We intend to have cost parity with current manual laparoscopic procedures."
Morgan explained that for any specialist robot to have commercial success, it must provide an added benefit that existing technology can't provide.
"You need it to be used by surgeons who are willing to pioneer new procedures or applications with robots," he said. "The robots also have to be engineered correctly so they perform the right functions."
Morgan added that robotics developers need to prove that the clinical benefit will apply to a reasonable number of patients so the procedures are frequent enough to justify the investment. "Commercial success will be dependent on broader applications in existing vitreoretinal surgery or use in new therapies."
Heather R. Johnson is a freelance writer based in Oakland, California.
[Top image courtesy of VIRTUAL INCISION; Second image courtesy of UNIVERSITY HOSPITALS LEUVEN]