Cook Medical designs new method to fix blocked salivary glands..

Cheri Smith works on a hand-sewn stent at Cook Medical. Cook has started selling tools tiny enough to thread into blocked salivary ducts

Your cheeks swell up when you eat or even think of eating.

Infections sometimes set in.

Surgery to fix the problem can cause dry mouth or, far worse, partial facial paralysis.

All because of a blockage in the tiny salivary ducts in your mouth.

The problem ranks among the touchiest of ailments. Live with it, and even the simple pleasure of food causes discomfort. Opt for surgery, and the risks are frightening.

A Bloomington medical device company thinks a better solution is at hand for this medical no-win situation.

Cook Medical, known for its expertise in fashioning products fitted for small spaces in the body, has started selling tools tiny enough to thread into the salivary ducts.

The set of miniaturized tools has the potential, Cook and medical experts say, to take the precariousness out of treating salivary duct blockages. The tools allow an outpatient procedure with minimal health risks.

“It’s a tremendous opportunity to have a different option to treat their pain,” said Thomas Cherry, global leader for Cook’s head and neck surgery division.

Cherry has in mind the 80,000 to 100,000 Americans a year who suffer from salivary gland blockage. (Twice as many are men than women.) Typically the blockage is caused by stones, such as the ones that form in the kidneys when an imbalance of minerals in the body creates a crystallized clump of minerals and acidic salts.

But while kidney stones are easily dealt with by drinking more water, breaking them up with sound waves or inserting a tube into the body to remove them, salivary ducts — thinner than an ink pen cartridge — were too small to enter to remove the stones.

What changed all that was the development of super-small endoscopes by the German medical device firm Karl Storz in the late 1990s, Cherry said. Storz came out with tiny, camera-equipped tubes that could give images of the insides of the four main salivary ducts (two under the tongue and two on the upper cheeks).

Toronto head and neck surgeon Dr. Jack Kolenda heard about the tiny endoscopes about 10 years ago and traveled to Switzerland to be trained in using them.
he only problem: While the tiny endoscope let him see the blockage, nobody made tools small enough to clear it out.

“I was kind of trying to innovate my own tools,” Kolenda said last week. “We needed better instruments, and we also needed better access (to the ducts).”

About two years ago, Kolenda began discussing his ideas with Cook, which specializes in minimally invasive tools that avoid surgery.

“We had very good discussions as to what I needed,” Kolenda said. Other medical companies he talked to “were interested, but they didn’t see the market,” he said. “Cook’s approach was, ‘We want to help the patients,’ which was very refreshing. That’s what cinched the deal.”

Working with Cook engineers, Kolenda helped invent a device called an introducer sheath that holds open the salivary duct and protects it while a wire guide is inserted inside. An extractor holding a wire basket then snags the stones.

“The biggest challenge for us has been in miniaturizing the components,” Cherry said. The wire guide and extractor are much smaller versions of existing urology tools that Cook sells.

So far, the new Cook tools have been used on about 600 patients, but Cook is now gearing up to make them widely available.

Kolenda said he expects the Cook products, including the sheath, dilator and stone extractors, to be heavily used by doctors within a few years. They should significantly reduce the cost and risk of treating salivary duct blockage, he said.

Cook’s process requires a relatively short outpatient procedure of about 90 minutes that can be done in a clinic. Kolenda said he has had a 90 percent success rate on his patients.

In contrast, the surgical approach entails removing the affected salivary gland, with the patient typically under anesthesia in an operating room. With surgery, there is a 30 percent chance of temporary or long-term partial facial paralysis because the salivary glands are near fine nerves that control muscles for blinking, smiling and other facial movements. The nerves can be inadvertently cut during surgery.

The paralysis risk has led many patients to refuse surgery and put up with the side effects of the blockage, such as infections and swelling of the cheeks while eating.

“This condition can have significant impact on their lives,” Kolenda said. “I have patients . . . who don’t want to go out (to eat). They can’t enjoy their life. It’s a huge social restriction.”

The cost of surgery can run into the thousands of dollars. Cherry said the cost of using the Cook tools is much less, but he couldn’t say by how much because costs vary depending on doctors’ charges.

For Kolenda, working with Cook has gained him some fame: His name has gone onto the sheath product.

“In a way, it’s an ego booster,” Kolenda said. “It’s nice to have that.”

Kolenda collects royalties from Cook on sales of the sheath, which has a price tag of about $140. He figures he’ll put the money toward his son’s education.