Hamilton, Ontario-based Mariner Endosurgery Inc. has won Health Canada approval to test a computer-assisted laparoscopic surgery system in February at Ontario's Hamilton General Hospital. Mariner President and COO Mitch Wilson told BioWorld MedTech the study is a vital part of the Laparoguard navigation system's acceptance by the FDA and laparoscopic surgeons.
"What we're interested in finding out with this pilot study is just how much safer it makes certain laparoscopic procedures, like gall bladder removal and hernia repair, and how it improves surgeons' confidence as to where their tools are during surgery."
Wilson likened the Laparoguard navigation platform to the tracking system on the windscreen of a fighter jet. Instead of enemy aircraft, surgeons will annotate areas of the body at risk to the encroachment of surgical instruments during surgery. "We overlay those critical areas defined by the surgeon and track where all the surgical tools are moving," Wilson explained. "If any of those tools begin to approach those defined areas of risk, we set off an alert."
The visual or sonic alert comes courtesy of a camera mounted onto a laparoscopic probe designed by company CMO and surgeon David Langois. Under its careful gaze are the instruments used during surgery, each mounted with a tracker with a different shape and color to distinguish it from every other surgical instrument (e.g., the scalpel from the hook scissors).
Many of these tools, Langois told BioWorld MedTech "are coming into your peripheral vision from different angles during surgery." Some are very hot and may burn tissue. Others tear tissue.
"A lot of injuries go unnoticed and a lot of it has to do with the limited field of vision during the laparoscopic procedure," Langois said. "When you look at our computer screen, it will tell us instrument three is out, for example, so that we can move it back into the safe zone."
This is not the first attempt to develop better laparoscopic surgical monitoring. But Wilson said laparoscopic surgeons felt encumbered by goggles and suffered from eye strain from the first 3-D monitors that came out several years ago. Far worse, he said, were their "depth cues," those physiological and psychological cues the human visual system uses to determine distances between objects.
"Using Laparoguard, even if you're working on a two-dimensional screen, you're receiving 3-D cues from the software in real time that literally point where your tool needs to go to get back into the safe zone," said Wilson.
In addition to enhanced laparoscopic depth cues, the Laparoguard reduces reliance on very large and expensive CT scanners to create multiple images before and during surgery, said Wilson. "Technicians also spend 30 minutes registering the patient under anesthetic just to line up the images to make it work. We don't do any of that," he said.
Langois and other surgeons liked how the Laparoguard system worked during animal studies and how the Laparoguard probe felt in their hands. The trick now is to see how well the device works on actual patients. An initial cohort of 10 patients has been scheduled for surgery using the system during the pilot trial at McMaster University's Department of Medicine.
Angel investors experienced in medical device and robotics startups and surgeons who tried and liked the laparoscopic system have helped bankroll its development to this point. That included Langois who owns the Laparoguard patent and who along with Mitch Wilson "bootstrapped" the company until those larger investors became involved.
Also of help has been the C$250,000 in public grants from Canada's National Research Council, Ontario's Centers for Excellence and the Toronto-based accelerator program, Mars Embark. Wilson expects early revenues to begin flowing into the company coffers this quarter. "The goal is build Mariner and to accelerate growth the best way we can. We're a small company, but we're proud of our team, and so we're going to make a go of it."