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Closing the gaps

OTTAWA — Combining concepts for woodworking to create surgical tools seems quite peculiar. Yet an Ottawa surgeon and Lee Valley Tools founder have teamed up to make some of the most innovative new medical and surgical instruments which give more conventional systems a run for their money. But the company is struggling to get its products licensed in Canada because of lack of regulations.

 

It began with “the world’s best scalpel,” a scalpel shaped like a carving knife but with the functional capability of a retractable Exacto knife, according to Michael Bell, a plastic surgeon at the Ottawa Hospital.

After years of research, development and a seven-figure investment in the company, Bell and the company’s founder, Leonard Lee, started making medical products and systems they say are more successful than more conventional medical devices.

Leonard Lee is holding a rubber arm demonstrating the use of the wound closure system
Leonard Lee, age 71, has designed some of the most innovative new medical products on the market.

“We have produced products that are stunningly good at what they do,” says Lee.

Cutting edge technology

The focus of the designs is the manipulation of a patient’s skin with the use of mechanical devices to facilitate complex operations.

Probably the most innovative of Lee’s designs is the dynamic wound closure system.

The system consists of one of three different types of anchors: adhesive, skin and button. Different anchors are used depending on the tension of the skin on either side of the wound. Elastic silicone cords are fed through a wire cleat that is attached to the anchors. The cord, which is called an elastomer, can be laid over the skin or inserted through the skin like sutures for better grip. The elastomers are labeled with black lines to indicate the level of tension that is put on the wound. The elastomers are tightened every three to four days until the two sides of the incision meet and heal or are stitched or stapled together. This process can be compared to tightening a corset. The only difference is that while a corset uses one string to connect all points, the wound closure system uses an elastomer for every entry point on either side of the wound.

'You can't measure the value of being able to close an abdomen.'

By attaching the anchors and using elastomers the surgeon is able to slowly stretch the skin that retracts upon creating an incision, and pull it together.

Previously, it would take two weeks to stabilize the wound and one year to heal says Bell.

But, with the Canica system, it takes less than three days to close a medium-sized incision.

Prior to this system, plastic surgeons would use tension sutures, which were prone to ripping skin because of the high tension of the retracted skin, or rely on skin grafts to patch the open wound rather than closing it.

Bell says that with old techniques “the person is crippled with a chronic hernia.”

But, with the wound closure system, Bell says that “you can’t measure the value of being able to close an open abdomen. The patient walks out of the hospital without a skin graft, without the need for another operation and without a painful donor site.”

Canadian innovation vs. implementation

Despite the benefits, the problem facing Lee is the lack of acceptance of his products by many surgeons, hospitals, and the health care system.

SLIDESHOW: Canica products

Warning: Surgical photographs are graphic in nature. Viewer discretion is advised.

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Julia Barry, the manager of clinical and regulatory affairs at Canica says that trying to convince people within the health care system to incorporate their products is difficult.

She says despite extensive research and practical proof in war zones of the efficacy of Canica products, the lack of a drive towards accepting new technologies and systems by surgeons is making it difficult to conduct proper and objective research that would be accepted by the health care system.

Lee admits he didn’t consider the difficulty in trying to change the current practice in medicine.

He says that the health system and the hospital budgeting structure make it difficult, because money cannot be transferred between departments, or taken from equipment or patient care costs.

The cost of the system would have to be paid by the department where it is used, usually in the operating room, but the benefits would only be visible in intensive and home care.

Open abdomen with anchors placed along the incision with elastomers in place ready for the first tensioning
Wound closure systems manipulate the elasticity of the skin in order to allow the closing of the wound with less scarring.

But Bell explains that “you almost eliminate home care, because the patient can walk out of the hospital with this system on.”

At the Ottawa Hospital, Civic campus, surgeons using the system estimated that the average patient cost saving where a Canica device was used was $8,000, 10 times the cost of the system itself.

Still, Lee says that the systems are not used continuously in any other hospital in the city.

The American health care system on the other hand provides monetary incentives for surgeons who use Canica products, because of the cost savings. This is contrary to Canada, where incentives are not given and surgeons are reluctant to change their ways because of the extra training the new technologies would require.

Lee and Bell agree that as young surgeons who are more welcoming to change phase out their predecessors, Canica products will catch on faster because they will become the norm.

For now, Canica Design research and development has halted, but Lee and his team are working on getting their products licensed so they can be used more widely in hospitals in Canada and around the world.

Like any good medical device, Bell says, “it takes time to catch on.”

Related Links

Description of the way some Canica products work

 

 

Strange design

Canica Design was founded by Leonard Lee (founder of Lee Valley Tools) in 1998.

The company, which has only 12 employees is located in Almonte, Ontario, a small town 50 kilometres west of Ottawa.

Lee first teamed up with Ottawa plastic surgeon Dr. Michael Bell in 1999 to create medical products inspired by the tools used in woodworking.

Bell first envisioned a partnership with Lee after he purchased a carving knife from Lee Valley Tools. Fascinated with the knife's dexterity, Bell tried the knife in his procedures.

He found that Lee's carving knife was easier to manipulate in his hands in order to more precisely perform surgeries. He compared the regular scalpel to the carving knife as a fine writing utensil compared to a fine writing pen.

He called Lee and suggested that his woodworking tools were better for medical purposes than the ones he was using.

They started designing a wide range of medical systems, but has still not been widely recognized in Canada.

The company does however hold several patents in the U.S.

Source: Canica Design

 

Order of business

Even though the company has been around for a decade, it only started making a profit three months ago.

That does not include the mounds of debt the company has accumulated over its life.

The reason it has been able to operate this long according to Lee, who receives no research grants, is through the limited number of individuals who have invested in the company. But most of the funding for research and development for Canica products is through other small companies Lee has established.

One of these companies, or a brand rather, is Chestnut Tools. The subsidiary company that is stationed with Canica Design creates household gadgets like magnetic flashlight holders and cooking spatulas, and has been the major funder of Canica technologies.

Source: Leonard Lee

 

Patch work

Lee and Bell’s wound closure system eliminates the use of skin grafts, which was used almost exclusively to patch over large wounds.
A skin graft involves cutting a healthy piece of skin from a donor site on the patient’s body, usually areas covered by clothing like the buttock or the thigh and overlaying it on the wound.

Depending on the size of the wound the piece of skin extracted from another part of the body may be only a few layers, or it can be all layers of skin and the muscles of the flap.

However, it creates another wound that could be avoided. As well, the patient would be left to suffer from a chronic hernia (where an internal organ bulges through a weak part of the muscle) because the wound would never fully close and take over a year to heal while the patient would be basically bedridden.

Source: Medline Plus, Medical Encyclopedia

 

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