December 3, 2009 | The Bulletin

Local physician’s medical device may help recovery after surgery

By Markian Hawryluk / The Bulletin

Published:December 03. 2009 4:00AM PST

Andy Tullis / The Bulletin

Dr. Edward Boyle, a physician at Inovia Vein Specialty Center in Bend, invented a device that helps clear chest tubes after heart surgery. “I started thinking of ways we could develop a tube that would perform that function better,” Boyle said.

Andy Tullis / The Bulletin

The PleuraFlow Active Tube Clearance System, BendsurgeoniBend surgeonDr. Edward Boyle, uses a wire ring to clear clots in chest tubes aftersurgery. That allows doctors to use smaller diameter chest tubes which are morecomfortable for patients.

Pleuraflow

When the chest tube is inserted, the Pleuraflowcatheter tube is attached between the chest tube and the collection device.

Pleuraflow

The Pleuraflow features a metal ring attached to along wire that is pushed into the chest tube almost to the end. In order tokeep the system closed to reduce the risk of infection, the wire is pushed andpulled through the chest tube using a magnet on the outside handle.

Pleuraflow

In order to keep the system closed to reduce therisk of infection, the wire is pushed and pulled through the chest tube using amagnet on the outside handle.

Pleuraflow

Once a clot begins to form, a nurse only needs touse the magnetic handle to pull the wire and metal ring, which pushes the clotmaterial down toward the collection device.

Once the clot material is pushed into thecollection device, the metal ring and wire can be pushed back into the chesttube, ready to remove future clots.

The problem

After open-heart and other invasive surgeries,temporary tubes inserted into the chest are used to drain excess fluid or air,which can lead to complications or even death if not properly drained.
Chest tubes are long, clear tubes that are connected to a closed drainagesystem that uses suction to remove excess fluid and air.
Chest tubes often clog as the blood draining through them clots. These clotscan interrupt drainage and cause complications. Traditionally, the only way toremove clots from chest tubes is to use methods that can be uncomfortable forpatients. In addition, a clot in the internal section of the chest tube mightgo unnoticed.

The solution

The catheter system Dr. Edward Boyle developed aims to make removing clots fromchest tubes easy and safe for patients. Here’s how it works:

•1: When the chest tube is inserted, the Pleuraflow catheter tube isattached between the chest tube and the collection device.

•2: The Pleuraflow features a metal ring attached to a long wire that ispushed into the chest tube almost to the end. In order to keep the systemclosed to reduce the risk of infection, the wire is pushed and pulled throughthe chest tube using a magnet on the outside handle.

•3: Once a clot begins to form, a nurse only needs to use the magnetichandle to pull the wire and metal ring, which pushes the clot material downtoward the collection device.

•4: Once the clot material is pushed into the collection device, themetal ring and wire can be pushed back into the chest tube, ready to removefuture clots.

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Trained as a heart surgeon, Dr. Edward Boyle of Inovia Vein Specialty Centerin Bend knowsthe risk of fluid buildup around the heart and lungs. Such fluid can interferewith breathing or lead to serious complications, including a collapsed lung.It’s why doctors insert chest tubes after heart surgery to let fluids drain outand to monitor for continued bleeding.

“They have a reputation for being very painful, andwhat I learned over the years is they don’t work that great,” Boyle said. “Theytend to get a goo clogged in them that causes them not to function.”

And when they do get clogged, the fluid doesn’tdrain properly and patients go home with a high risk of complications.According to a recent study, about 60 percent of patients are discharged afterheart surgery with fluid around their hearts and lungs.

Because of the risk of clogging, doctors tend touse larger diameter chest tubes, and patients wake up after surgery with gardenhose-size tubes sticking out of the sides of their chests. Meanwhile, nursesare charged with keeping the tubes flowing. They tug on them, tap them, bendand squeeze them to break up the clogs, none of which is comfortable for thepatient.

“I started thinking of ways we could develop a tubethat would perform that function better,” Boyle said. In 2003, he came up witha simple solution to the problem: a chest tube with a wire loop inside that canbe used to dislodge clogs as they form. With a lower risk of clogging, the tubecould be much smaller — the width of a drinking straw — and more comfortablefor the patient.

Six years later, Boyle’s idea for a better medicalmousetrap is about to become a reality. The device will be tested during actualsurgeries for the first time early next year.

It’s a classic example of how innovation inmedicine occurs. Unlike with pharmaceutical drugs, which are typicallydeveloped by large companies with billion-dollar research and developmentbudgets, a large percentage of medical devices are invented by practicingdoctors like Boyle, who see a need and figure out a way to meet it.

Increasingly, medical devices are coming to marketonly after physician entrepreneurs form small startup companies to bring adevice from idea through development, testing and regulatory approval. And ifthey succeed, they’ll likely end up selling the rights to the product to alarge device company that will manufacturer and market it to hospitals andphysicians.

The device has the potential to drastically improvemedical care for patients, and Boyle said a number of surgeons who have learnedabout the system are already asking when they can get it.

In October, Boyle learned the device had won theprestigious Techno-College Innovation Award from the European Association ofCardio-Thoracic Surgery.

Using a small startup company for devicedevelopment, as Boyle has done, in many ways shields doctor-inventors from thepotential conflicts that can come along with funding from large devicemanufacturers (see “The ethics question: Do corporate ties raise conflict ofinterest issues?”).

But that shifts the financial burden onto thephysicians, their partners and investors. And few devices make it intohospitals and offices without the sales and marketing staff of these large companies.

“We all have to recognize that new innovations, inmedical devices especially, have always come through at some point clinicaldoctors and interaction with industry,” Boyle said. “That’s something we allbenefit from — society, patients, everyone.”

A recent analysis by researchers at the FuquaSchool of Business at Duke University showed justhow important physicians are to the innovation process. They found that one infive medical device patents are held by physicians and that devices invented byphysicians were more likely to represent significant advances and to be muchmore profitable than those invented by non-physicians.

“The physician is often the only one who knows whatmight be needed,” said Matt Hoskins, a medical device engineer in Bend. “It’s just hard foran engineer, a businessman, a marketing person, to get that kind of insightinto the needs out there.”

Even when medical devices are invented bynon-clinicians, it often takes a physician to understand whether the productwill work in a medical setting and to evaluate its effectiveness.

“Our country would not like the products that wouldcome out if you had engineers in a vacuum designing medical products,” said Dr.Knute Buehler, an orthopedic surgeon with The Center: Orthopedic &Neurosurgical Care & Research in Bend.

“It’s something I’ve seen over and over again. I’vebeen involved in redesigning products that have not had enough physiciansurgeon input from the beginning. It’s just too hard as a non-physician toreally know the issues, and to try out the products and work out the bugs.”

When doctors work on developing cutting-edge toolsand techniques, patients also benefit. Such doctors must be much more in tunewith the state of medicine in other places and develop relationships with otherdoctors involved in innovation. And patients often get access to devices soonerthan they otherwise would, as doctors validate and test new technology.

“The type of stuff that Dr. Boyle does, it reallyenhances the reputation of the medical community,” Buehler said. “If you’regoing to be a world-class medical institution, you can’t just use scientificdata, you have to generate new data, and that’s really distinguishing aworld-class place from just another medical community, Hopefully this willbuild and become a bigger and bigger emphasis here.”

Device development experts say it takes hundreds ofthousands of dollars to bring a promising device through the so-called “valleyof death” between discovery and commercialization. Boyle and Dr. Marc Gillinov,a cardiac surgeon with the Cleveland Clinic, co-founded Clear Catheter Systemsto develop and test the chest tube clearing device.

“What worries me is sometimes the overall economicenvironment can make that difficult,” Boyle said. “There’s a lot of uncertaintyabout the future, but we know that the country is going to need innovation andthis is how it’s going to get done.”

The company received an early investment of$150,000 from the Bend Venture Conference in 2006 that helped fund the earlysteps of bringing the device to market. Boyle and Gillinov expect approval tomarket the device from Canadian regulators by the end of the year and have madearrangements to begin testing the device in surgeries at the Montreal Heart Instituteearly in 2010. They have also submitted their regulatory application to the FDAfor clearance, a process that usually takes 90 to 180 days.

Such success is only adding fuel to Boyle’screative fire. He and his partner at Inovia, Dr. Andrew Jones, are working on anew device to treat spider veins, and they are serving as scientific adviserson some other new devices.

“I think it shows a commitment to the patients andthe disease processes we treat,” Boyle said. “You’re constantly having tojustify your ideas to other people, to companies that come and want to marketit. You’ve got to be on top of your game to do it. You can check; I don’t havea good golf game.”

MarkianHawryluk can be reached at 541-617-7814 or [email protected]

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