(HealthNewsDigest.com) - "There's got to be a better way." Dr. Peter Dillon, chief of surgery at Penn State Health Milton S. Hershey Medical Center, likes to drop in on his doctors at work, and on that day in early 2010 he was watching as staff surgeon Dr. Don Mackay affixed thin metal plates to the broken ribs of an elderly patient. Mackay had modified the standard way of fixing ribs, making it less traumatic for patients, but the procedure was still long, laborious, and somewhat bloody.
“I just said, there’s gotta be a better way,” recalls Dillon. “Why can’t you do that minimally invasively?”
The treatment of rib fractures has long been ripe for an overhaul. A typical scene of the conventional method, which attaches a plate to the outer surface of a broken rib, has the patient on his side, a slab of flesh from waist to armpit folded back to reveal the pale ribs and the red intercostal muscles. “Skeletonizing” is how one of Dillon’s colleagues describes the operation, “like something out of Game of Thrones.”
The surgery is so hard on patients that it is used only in cases with multiple breaks, especially of adjacent ribs. Such a cluster of broken ribs causes “flail chest,” a condition where that section of the ribcage moves opposite the way it’s supposed to move, interfering with the ability to breathe. The broken ribs have to be stabilized, or the person runs a high risk of dying due to pneumonia or other infections.
For patients who break just one rib, or who don’t have flail chest, the surgery usually isn’t worth the trauma; standard treatment is to leave the rib alone. “You take aspirin, go home, and suffer,” says Mackay. “For weeks.” He knows from personal experience: A few years ago he broke several ribs in a car accident. The native of South Africa with strong Scottish roots managed to play the bagpipes at his nephew’s wedding four weeks later, but it was excruciating.
A broken rib hurts like hell every time the broken ends move, which is every time you breathe. That can lead to more serious problems, especially for older patients and others whose lung capacity is limited. To minimize the pain, you breathe as shallowly as possible, which leads to fluid build-up in the lungs, which leads to infections, which puts you on a ventilator—or in the morgue. Because of how much they compromise the ability to breathe normally, broken ribs are the second leading cause of trauma deaths.
To devise a better way to ‘fix,’ or stabilize, broken ribs, Mackay and Dillon enlisted the help of Dr. Randy Haluck, chief of minimally invasive surgery at the Medical Center, and Barry Fell, a biomedical engineer whose company, TPC Design, specializes in orthopedic devices such as artificial hips and knees. Like Mackay, Fell has gone through the pain of broken ribs—in his case, many times, most due to his lifelong enthusiasm for playing ice hockey.
The Penn State group thought attaching the plate to the inner surface of the broken rib, the side facing the lungs, would be less traumatic than the standard procedure, because it would leave the overlying tissue largely undisturbed. A device already existed for doing some types of minimally invasive surgery in the chest: the thoracoscope, which carries a fiber-optic cable through a short slit in the chest wall and transmits live images to a video monitor. The view from a thoracoscope inserted low in the ribcage looks like a room in a cave, the smooth arched walls glistening pink and white. From this vantage point, many of the ribs are visible and could be fixed without repositioning the scope. The surgeon can see exactly where the break is—something not always possible from the outside or even with an x-ray. “Once you are oriented to where things are, you have a wonderful, magnified, high-definition view,” says Haluck.
While the surgeons considered how to use a thoracoscope to fix ribs, Fell did what comes naturally to an engineer: He tinkered.
“He ended up going to Giant and getting a side of ribs from the meat department,” says Dillon. “He called me up one day and said, ‘Hey, come on over. I put some plates and screws into some ribs; what do you think?’ ”
Fell’s plates looked good: solid, secure. Splinting ribs from the inside would work from a mechanical perspective. But was it do-able in real life? The thoracoscope would let them see into the chest; next they had to figure out how to get the hardware in and attach it to the broken ribs, without making a big incision.
“You need to hold the screw; you need to get the screw and the plate to the right angle and location,” says Haluck. “And how do you then introduce a screwdriver that goes in, down, and up? Consider all the angles that you have in here, and where the breaks might be.
“It’s like building a ship in a bottle, with two or three parts simultaneously.”
Over the next several months, the group designed new hardware and a system that lets them bring a plate and screws into the chest cavity through two short incisions above the broken rib, while the thoracoscope provides a view of the injury from a slit lower down.
Their procedure is much quicker than the conventional method—less than an hour, compared to several hours—which greatly reduces the cost of the operation. Most importantly, the group says, by being so much less traumatic than the conventional surgery, it should speed recovery, keep patients off a ventilator, and get them back to their normal activities sooner.
Putting it into practice
In 2013 the group filed patent applications for the new system and licensed it to Synthes, the market leader in conventional rib repair hardware. Because it uses materials and methods—stainless steel, titanium, thoracoscopy—already approved for use in patients, it did not have to go through lengthy clinical trials. Instead, it quickly won a “510k clearance” from the FDA.
But it nearly died before it could be brought to market, when mega-corporation Johnson & Johnson bought Synthes and decided not to market the new system. And then, surprising everyone, J & J allowed Synthes to return the license to the group at Hershey.
“We were a little taken aback by that,” says Fell, “but we said ‘Thank you very much!’ Because it was already FDA-cleared, it had everything that’s required to market the product 90 percent completed.”
To take it the last ten percent, the team sought advice from Kevin Harter, director of Penn State’s brand-new Center for Medical Innovation. He first verified that there is a market for the procedure. Nationwide, around 100,000 people per year are seen at trauma centers, suffering from multiple broken ribs—a huge potential market for the new technique. And that doesn’t count the hundreds of thousands more with just one broken rib, especially seniors, for whom repair might be an excellent option now that there’s a minimally-invasive way to do it.
Then Fell started a business, SIG Medical, to produce and sell the system, now named AdvantageRib, in conjunction with the Medical Center. Ethics rules prevent the surgeons from taking a director’s or management role in the business, but they have invested in it, as have Ben Franklin Technology Partners and several private investors. SIG Medical also won the $75,000 top prize at Penn State’s Venture and Intellectual Property Fair last fall.
Although clinical trials aren’t required, the group wants to demonstrate that their system offers an improvement over current methods of rib fixation before taking it to market. This spring and summer, other surgeons at the Medical Center started trying it with living patients. Their first case was a tough challenge: a young girl with flail chest due to 13 fractures of eight ribs on the left side of her chest, caused by a car accident. The surgery restored the normal shape of her chest, allowed good lung ventilation, and reduced her need for pain medications.
If AdvantageRib continues to prove itself, the team’s next step is to ask leading surgeons around the country to try it. Harter calls this a “seed strategy” that relies on opinion leaders spreading the word, rather than on a sales force and advertising. Initially, at least, all prospective users will come to Hershey for training.
“You always hear about doctors going to Cleveland Clinic or Johns Hopkins to learn new techniques,” says Harter. “This is a Penn State technology. The first surgeries will happen here. The experts will be here.”