February 7, 2004
The Red Green Show meets ER
How a tool company came to make surgical equipment
By Sean Brad Evenson, National Post
Four years ago, during a struggle in a remote Arctic village, a suspect shot RCMP Constable Paul Descoteaux in the arm with a hunting rifle. The bullet tore the 27-year-old's elbow apart and pierced his brachial artery.
"There was a lot of bleeding," he recalled. "I passed out twice." As Descoteaux's partner raced him to medical help, fluid pooled inside the stricken arm. By the time he reached a hospital in Iqaluit five hours later, the arm was swollen thick as a firehose. Soon the pressure would cause circulation in Descoteaux's arm to stop. Starved of resh blood, his muscles would begin to die. He would face amputation.
So, like hundreds of Canadian trauma patients each year, he got a fasciotomy. Surgeons cut a deep trench down his arm to relieve the pressure. By the time Ottawa plastic surgeon Michael Bell saw him a week later, the wound measured 16 inches long by six inches wide. "It was pretty big," Bell said. Ordinarily, such patients get skin grafts to cover their gaping surgical wounds. But skin grafts heal poorly and look bad. Recovery can take months or even years.
Instead, Bell sewed two rows of metal clasps along the wound. Then he cinched them together with thick elastic tubes, somewhat like a Victorian corset, pulling the skin together. Within 10 days the wound's pink edges had kissed, a remarkable feat.
In a world of high-tech medical devices and million-dollar equipment, the contraption, unpoetically called the Wound Closure System by its creators, Canica Design Inc. of Ottawa, is a remarkably cheap and simple tool. Which makes sense.
Canica is the grandchild of a hand tool company, Lee Valley Tools, which sells chisels, saws and sharp knives for whittling. Who knows more about cutting, drilling and clamping? "The industry is oriented to big ticket items: life support systems and this sort of thing," said Canica president Leonard Lee. "So there's nobody left around to do the hand tools."
The wound closing system is more than a surgical novelty. In pilot use at the Ottawa Hospital, conservative estimates say the reusable $840 device saves between $7,000 and $8,000 a patient, allowing patients to leave hospital on average five days earlier. They also require less nursing care at home. Nor is the device simply a better mousetrap. "In wound closing, there is no mousetrap," Bell said. "There's really no alternative."
How does a company go from making wood joints to joining skin? Until he got a strange complaint from Bell five years ago, Lee had no ambition to enter the medical device trade. The former public servant had built Lee Valley Tools from scratch into a thriving mail order business by making high quality tools and listening to customers such as Michael Bell.
In 1998, Bell complained that his carving knives were getting corroded. Lee was curious. How would a steel knife used to carve little horses out of wood get rusty? Exactly what was this doctor doing with it? And this was no ordinary doctor. A pioneer in microvascular surgery, Bell is highly regarded in Canada's plastic surgery community.
"I told him it happened after I put them in the autoclave to sterilize them," Bell said. Lee was appalled. You're doing surgery with this thing? he asked. "I told him he had invented the world's greatest scalpel," Bell said.
The round handle on the Lee Valley knife was superior to old-fashioned, regular scalpels, he said. What is more, Bell said, he used no less than 17 different Lee Valley Tools in his clinic, from little brass calipers for measuring to sanding tools for dermabrasion, a technique to "refinish" the skin's top layers. "He scared the hell out of me because he was using these power-carving tools for surgery," Lee said. "But that's Mike."
Fear soon turned to curiosity. When Bell invited him to his clinic for a visit, Lee brought along a group of his tool designers. Before long, the toolmakers were ransacking Bell's purple surgery cabinets, holding up forceps, retractors and curettes, demanding to know their purpose and how they could be improved.
It was a marriage made in handyman heaven, The Red Green Show meets ER.
"Mike Bell is not only a very good surgeon," Lee said. "He's a mechanical nut, too. He owns more welding gear than most welders do. He's constantly making things and constantly adapting things and improving them."
Lee, who had been contemplating his retirement with increasing unease, saw a new opportunity. Before long, he launched Canica, hired a band of designers and started work with Bell to build a better scalpel.
"Look at this," Bell said, brandishing a scalpel in his Ottawa clinic. "Most of the tools we use [in surgery] were designed by people who have been dead for 100 years."
Indeed, the flat-bladed scalpel is uncomfortable to hold and manipulate. The Canica scalpel, by contrast, is round and easy to control. It also takes the danger out of changing scalpel blades, a source of many doctors' mortal wounds. Blades on the Canica scalpel can be ejected with a thumb click, like a mechanical pencil.
Next, Bell and Canica collaborated on a design to make hand surgery easier, by anchoring clasps that hold open the skin to magnets that stick to a steel operating surface. Known as the CHESS system, it allows surgeons to perform hand operations alone that often took one or two operating assistants.
In spite of their merits, however, these tools aren't unique. There are plenty of scalpels and hand retractors on the market, and surgeons are habitual creatures. Sales have not exploded. "The difference with the wound closure system is there's not anything else out there that occupies that niche," said Murray Allen, an Ottawa plastic surgeon. "If we had two or three other [devices] that worked almost as well, it certainly would have attracted as much attention."
The wound closing system was born after a grisly accident in a hospital. "I have a very dear friend who is about 400 pounds," explained Mike O'Malley, Canica's director of research and development. "He had an emergency appendectomy and they had a nightmarish time closing him." Because of his girth, surgeons had difficulty sewing him together, finally using a retention suture, a strong piece of thread.
"Well, he got out of bed one morning and his gut sort of split open and his abdominal contents [spilled] on to the floor," O'Malley said. "This created a life-threatening circumstance for [him], and they truly didn't know what to do with him."
As O'Malley watched the surgeons struggle to sew his friend closed again, the problem struck him as obvious; they were using an inelastic device in a completely elastic body. "And I said to the surgeon what about a bungee cord?" recalled O'Malley. "Aren't there elastic sutures? And he's looking at me like I'm a mental patient."
On Jan. 26, 2000, O'Malley and Bell retreated to the doctor's cottage near Val de Monts, Que. Over copious glasses of Shiraz wine, the two tossed the problem around. Bell conceded nobody had really thought about it before. It's just the way it's always been done, he explained. Back and forth from the sauna to Dodds Lake, until 3 a.m., they kept working on it.
One of the problems with wounds is, if left open, the skin retracts. Sometimes, the sticky edges heal on to the muscle inside the flesh. Often, they are just to stubborn to heal. "With the CHESS system, we already knew how to pull things apart [using elastics]," O'Malley said. "If dynamic retraction worked, why wasn't dynamic closure applied? Since they already had metal hooks and elastic bands to pull skin apart, they turned them around the other way. It was immediately obvious it would work. One of the hallmarks of Lee Valley Tools products is they seem so simple, it's like they've been around forever. So O'Malley and Bell's solution to the wound closing problem fits into the tradition.
One of their first patients was Const. Descoteaux. "They explained how it works and said they'd be willing to test it on me," Descoteaux said. "I said, 'Yeah, no doubt. Anything to avoid a skin graft.'" Every day, Bell would come by and cinch the elastics a little tighter. It was uncomfortable, but not terrible, he said "a five out of 10 for pain."
Two months after the bullet tore apart his arm, Descoteaux began to move his fingers. Reached on the telephone while on a surveillance post, he reported sensation in the arm is back to normal. "Now, except for the index [finger] it's come back," he said.
For Bell, who spent most of his life in academic hospitals, half the fun was working with the eccentric designers who work for Canica, like the fellow who tested elastic tape by covering his body with it for months at a time. "Even after he got married he tested adhesives all the time on his abdomen and chest," Lee said. "You'd be at a design meeting and he'd lift up his shirt and God damn, there'd be four sets of wound closure and anchors on his chest and abdomen. And he's be playing hockey and seeing whether or not they'd come off."
Like many designs, however, the true value of the Canica system only displayed itself when doctors started using it. Like a corset, the system stretches the skin over the wound, which squeezes swelling, forcing out lymphatic fluid and venous blood and allowing fresh blood to enter the region, which promotes healing. As a result, the system worked better than expected.
In Descoteaux's case, for example, Bell and O'Malley doubted the system would close the wound entirely. "Originally, the goal was to minimize the incision so the skin graft would be smaller," O'Malley said.
Now, Canica is looking deeper into the flesh, trying to pull together the fascia after surgery, instead of just the skin. "In two cases, we have managed to close the fascia using the system," said Murray Allen, who has tested all the Canica products in surgery.
Experts see many uses for the system, including closing lesions after radiation therapy. Beyond cost savings, patients fare better on the system. In an article published in November in the Journal of the American College of Surgeons, Bell and a team of researchers reported so far, no patients have suffered any complications.
Wandering around in his clinic in blue surgical garb, Michael Bell often pauses and stares, a little startled, as though he can't quite believe how well the invention works. Then he pulls out a chunk of wire, explaining his next prototype, clearly bitten by the bug.
Mike O'Malley, Canica's director of research and development, laughed fondly when he hears Bell is hard at work on another invention. "My main job these days is keeping [Bell] and the designers apart," he said. "Production in this place goes down for about two months after they get together and start blue-skying about the future."
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