Lee Valley Tools founder and doctor plan a revolution in the operating room

Sunday 30 July 2000 - Almonte, Ontario - Dr. Michael Bell is an avid woodworker and lifelong customer of Lee Valley Tools, so when the handle on his carver's knife kept corroding, he sent a letter to company president Leonard Lee.

As is his habit, Mr. Lee responded himself. He was puzzled. Why would the handle be rusting out?

Dr. Bell explained that, after three of four times in the autoclave, the handle developed a little corrosion around the tip. An autoclave uses pressurized steam to sterilize tools. Surgical tools.

"You're using this in the operating room?"

The surgeon told the toolmaker he had unknowingly designed the world's best scalpel handle. And thus began a collaboration that, this fall, will lead to the launch of a new line of products that could lead to an evolution in surgical hand tools, a field that hasn't progressed in more than 50 years.

Mr. Lee's new company, Canica Design, is developing manual surgical instruments that could allow surgeons to work, unassisted, during minor procedures and let them move more surgeries from expensive hospital operating rooms into office clinics. For patients, it could mean shorter operations, smaller incisions, less anesthetic and faster recovery times.

His design team is applying technological advances in what they know best -- cutting, fixing, drilling -- to medicine.

"Doctors told us for years they could get more specialized tools for woodworking than they can get for surgery," says Mike O'Malley, Canica's director of research and development.

The flat-sided scalpel still widely in use today was developed in 1915 and hasn't changed since. Surgical instrument makers have concentrated instead on high-speed drills and saws, endoscopes and other innovative, high-ticket tools that have allowed surgeons to do procedures they never before could.

But basic instruments have been a totally neglected area, says Dr. Bell, who is director of Canica's medical advisory board. Many are clunky and crude, and weren't designed for the minimally invasive surgeries doctors are now increasingly being expected to perform.

"The advantage that Lee Valley has is that we're really up to speed on manufacturing processes," Mr. O'Malley says. "We've learned about stainless steels and how to make things cost effectively, and cleverly."

Not that Leonard Lee had need of another career. Lee Valley Tools is one of the region's most successful privately owned companies. Every three years the company doubles in size. Born on a kitchen table 23 years ago, the company now employs 550 people, with stores across Canada and a booming mail-order business in Canada and the U.S.

But, at 62, Mr. Lee said it was time to make himself dispensable at Lee Valley Tools. Besides, he says, the company has good managers "who, to my chagrin, function without me."

"This is a chance to start again," he says from the renovated, century-old hardware store on Almonte's Mill Street that now houses Canica Design. It smells like wood chips inside. There are 12-foot ceilings, gleaming hardwood and an "editor's" office with framed OPW Prints and Varnishes calendars from the 1930s. The designers, who range in age from 24 to 79, work at computer cubicles in the front. A machine shop that's been tidied up for our visit is out back; oak and glass cabinets display the evolution in the design of the surgical tools Mr. Lee hopes to bring to market in October.

Looking tanned and relaxed, Mr. Lee explains how he wants to restore the long-since forgotten relationship between the makers of surgical instruments and the doctors who use them. So he and his designers have donned masks and surgical scrubs to watch Dr. Bell and other surgeons at work in the operating room to better understand the problems they face.

One of the biggest problem for reconstructive surgeons is how to keep things in place -- like a hand during carpal tunnel surgery. And who better than woodworkers know how to "hold stuff," Mr. O'Malley asks. "It's a fundamental part of woodworking."

Canica designers developed the CHESS hand fixation and retraction system. It consists of stainless steel pieces shaped like chess men that use powerful magnets to fix them to a stainless steel plate draped in surgical cloth. The surgeon moves the magnets around the plate to "capture" a finger, or spread others apart, and to hold the hand in place. Chemically milled, thin flexible retractors that look like miniature back scratchers can be hooked on to the magnets, allowing the surgeon to control the retraction himself.

The system has allowed Dr. Bell to perform, unassisted, carpal tunnel procedures in his clinic in 15 minutes, instead of the standard 45 minutes in an operating room with one or two assistants.

The design team has refined the scalpel that began life as a carving knife. Unlike traditional flat-handled scalpels, which are "really nothing more than a slab of steel with a blade stuck in the end," Mr. Lee says, the new scalpel handle is shaped like a pen, allowing for fingertip control and far greater precision and accuracy when cutting. And it has a unique safety feature: an ejectable blade.

"The most dangerous thing you can do is take a scalpel blade off a scalpel handle," says Dr. Bell, who has operated on six doctors and nurses who have lacerated fingers and hands removing blades from their non-disposable handles.

Getting stuck with a scalpel is one thing. Getting stuck with one contaminated with HIV or hepatitis is another. So far, the best traditional instrument makers have come up with is a disposable scalpel made with a plastic handle, "the most useless thing in the world," Dr. Bell says, because there's no weight or balance.

Canica has also developed a wound-closure system that essentially uses a series of steel clips and bits of thin, latex tubes to gradually and gently close large wounds, avoiding the need for skin grafts that typically leave a substantial scar. The system has been used to close a large, elbow-to-wrist skin defect resulting from a complication of a gunshot wound in an RCMP officer's arm; it helped save the leg of a teenage girl who last winter contracted necrotising fasciitis, the "flesh eating" disease.

They hope to develop small rods that can be used to rejoin fractured bones in hands, and new drilling bits for orthopedic surgeons. And their preference is for local manufacturers.

"The hope is that, over time, our design efforts will create and hopefully grow a community of small surgical manufactures [here] in the [Ottawa] Valley," Mr. O'Malley says. "It would be an ideal industry for our area."

Mr. Lee says the goal is to design instruments that would work well in field medicine -- UN disaster relief efforts, Third World countries.

Exact figures are hard to come buy, but Canica estimates that the global market for surgical hand tools is about $70 billion annually. Capturing even a fraction of that market could rival the success of even Lee Valley Tools.

The company founder is excited and enthusiastic. Mr. Lee sounds like a medical student when he talks about diabetic ulcers and bedsores and how wounds must close by "secondary intent." He keeps colour pictures of gaping wounds that have been repaired with his new wound closure system in his briefcase.

"It's possible that we might be able to ..." Mr. Lee begins, then stops. "Surgeons might be able to ..." he corrects himself.

"This is not a God complex. It's problem-solving, really, and that's always a lot of fun. It's significant if a doctor is unable to do a procedure because he doesn't have the tools he needs.

"And it's a marvelous thing to be able to design something that will allow him to do it."


Sharon Kirkey
The Ottawa Citizen
"http://www.ottawacitizen.com/city/000730/4536128.html"

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