BELGRADE -- Some day, Dr. Roderick Brown hopes, thousands of patients will have their hernias fixed in a way that's minimally invasive and less painful.
Brown, a doctor with the Glacial Ridge Health System of Glenwood, invented a hernia repair device that entered the market recently.
Ten years of patience, ingenuity, trial and error went into developing the self-expanding polymer mesh and nickel-titanium device.
Its manufacturer, Minnesota Medical Development Inc. of Plymouth, has trademarked it as the Rebound Hernia Repair Device.
Brown said it has been "a real learning experience" to help nurture a new medical device from idea to reality.
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"It's been a wonderful experience learning about the process of developing something," he said. "I've been fortunate to have the opportunity to come up with an idea that had the potential to come into the marketplace."
As a family doctor and general surgeon, Brown has repaired countless hernias.
It's a common surgical procedure. Every year, hundreds of thousands of Americans must have a hernia fixed -- a weak area of muscle, usually in the abdomen, that can enlarge over time and allow internal organs to bulge through.
Years ago, hernias were simply sutured shut. Over the past two decades, surgeons began using tension-free repair, in which the hernia is covered with a piece of mesh that allows normal tissue to grow back over the mesh.
"It was a big advance," recalled Brown.
But it wasn't perfect. Even though better, more lightweight meshes were developed, they still had to be anchored with tiny tacks or staples to keep them in place, and patients often had post-surgery pain.
It often took considerable dexterity for the surgeon to insert the mesh and maneuver it into place, all the while working within the confines of a small laparoscopic incision.
"I just felt there was a better way to do it," Brown said.
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He began experimenting. Maybe there was a way to make the mesh self-expanding so it would be easier to handle. Maybe a supporting structure could be developed that would reduce the need for anchoring devices and allow patients to heal more comfortably.
Working patiently at his kitchen table, Brown developed some trial samples of the Rebound.
One of the big challenges: finding materials that could safely be used in patients.
"This is meant to be permanent so you have to use materials that are biocompatible," Brown said.
There already was a good safety track record for polymer mesh, but what Brown needed was something for his device's self-supporting frame.
When he learned of an alloy called Nitinol, he saw the solution. Nitinol, made of nickel and titanium, also is used for stents. The lightweight alloy has a super-memory, allowing it to bend or crunch and then return to its original shape.
Brown traveled to California to talk to a manufacturer who makes Nitinol wire and who helped him develop a prototype alloy-and-mesh device.
In 2000 he received approval from the Honduran government to go to Central America and test the device through clinical trials with real-life patients.
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It was critical, however, to have an alliance with a medical device manufacturer if his invention was ever to be marketed and widely used.
"It's not something you can start and say, 'I'm going to go off and do this by myself.' It's not realistic," Brown said.
Through his patent attorney, he was introduced in 2003 to Minnesota Medical Development Inc. The Plymouth company, founded in 2001, makes a variety of medical devices and has particular expertise with Nitinol.
"If it wouldn't have been for that introduction, this might not have happened," Brown said. "I would never have been able to have done it myself... It's been a real collaborative effort."
"It fit perfectly for us," said Steve Nuss, chief marketing officer at Minnesota Medical Development Inc.
MMDI studied Brown's concept and decided it was promising, Nuss said.
"This seemed to address some of the difficulties of placing the mesh," he said. "We looked at the market, of course, and saw what was out there. The regulatory issues weren't too complex."
Surgery also is unlikely to be replaced anytime soon with a pill that fixes hernias, thus ensuring a long future use of the Rebound device.
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Over the next few years, MMDI and Brown worked together to refine the device, test it, address the manufacturing process and apply for U.S. Food and Drug Administration approval.
They came up with three different shapes for the mesh. They checked the device's durability by putting it through 10.5 million cycles of flexion. They evaluated its shelf life. They solved the technical challenge of joining the frame by coming up with a laser-welded Nitinol coupling.
"It's a lengthy process," Brown said. "You've got your family. You've got your work. You go to meetings. You talk to people. Things would sort of come together and then things would screech to a halt."
Pre-marketing feedback from surgeons has been positive so far, he said.
The Rebound -- which was recently named an innovation of the year by the U.S. Society of Laparoendoscopic Surgeons -- is being sold to hospitals in a package of two for $475.
This is more expensive than a standard polymer mesh, Nuss said. But it eliminates the extra $250 cost of tacks, involves less time in the operating room, reduces the risk of damage to nerves or blood vessels, and promotes faster recovery time for the patient, he said.
"People are very excited about the product. We just need to get some people using it," he said.
Many of the best medical product innovations come from doctors themselves, rather than from engineers, Nuss said.
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"You really have to identify a medical problem, how to do something better," he said. 'That of course comes from the physicians who are working every day on patients."
Clinical trials will be undertaken in the United States to further evaluate the device. Test marketing also is being conducted in Europe.
Between 10 and 15 percent of hernia surgeries are now done laparoscopically. Brown thinks the Rebound will raise this number.
"Hopefully we'll be able to have an improvement and increase the minimally invasive approach for repair of hernias," he said. "I think this is going to work much better... As soon as I get some, I'll use them myself."
