It requires a remarkable confluence of factors to develop an innovative technology such as the minimally invasive rib fixation system invented by surgeons and other scientists at Penn State Health Milton S. Hershey Medical Center.
Physicians with curious, creative minds who are willing to work into the “white space” between specialties are essential in that endeavor. But the best ideas don’t move from the imagination into the operating suite without teamwork and infrastructure — including extensive input from device engineers, years of testing, FDA scrutiny and investor buy-in — as well as a university culture that continuously supports innovation.
Such a culture is promulgated throughout Penn State, including by President Eric Barron’s Invent Penn State initiative and the Center for Medical Innovation. That forward-looking atmosphere has been crucial to the development of what is now known as AdvantageRib — an invention that in turn helped spur the creation of Surgery Innovation Group (SIG) Medical, now a medical tech incubator and problem solver for the entire Department of Surgery.
‘A Better Way’
Peter Dillon, MD
The impetus behind the rib repair device and procedure was a simple comment in 2010 by Peter Dillon, MD, chief of surgery at Hershey Medical Center: “There’s gotta be a better way.”
He was observing Donald R. Mackay, DDS, MD, FACS, FAAP, who was stabilizing the ribs of an elderly patient on the outside of the bone using metal plates. It was an invasive operation lasting several hours and requiring an extensive incision to expose the ribs by pulling back skin and muscle.
Although Dr. Mackay was not aware of it, surgeons in Germany and Japan were the early innovators of the external repair procedure. Dr. Mackay started using the same kind of plates he used to stabilize facial bones for reconstructive surgery during his work as chief of the Division of Plastic Surgery at Hershey Medical Center. Dr. Mackay, now William P. Graham III professor of plastic surgery and associate chair of the Department of Surgery, notes that studies regarding the external rib fixation procedure showed it helped reduce hospital stays, time on a respirator and even mortality. Still, its duration and invasiveness underscored the need for additional options.
“We got some pork spareribs from a local butcher to work on AdvantageRib. The first side of spareribs was given a nickname by Barry Fell: It was called Chester.”
— Donald R. Mackay, DDS, MD, FACS, FAAP, William P. Graham III professor of plastic surgery and associate chair of the Department of Surgery at Penn State Health Milton S. Hershey Medical Center
A Significant Threat
Dr. Mackay’s pursuit of an improved technique to stabilize broken ribs stemmed in part from personal experience. After a car accident, he experienced flail chest, a condition in which four or more broken ribs cause the rib cage to become unstable and breathing actually moves the ribs inward rather than outward, something called “paradoxical movement.” He uses one word to describe the ordeal: “Pain.”
When breathing becomes painful, patients tend to breathe shallowly, explains Randy S. Haluck, MD, chief of the Division of Minimally Invasive and Bariatric Surgery at Hershey Medical Center and part of the team that designed AdvantageRib. Deep breathing and coughing help expel dust, pathogens and other contaminants, so when those processes are inhibited, especially for older patients, pneumonia can develop — sometimes leading to death. In fact, of the 150,000 rib fracture patients admitted at trauma centers in the U.S. each year, up to 10 percent die, according to a 2017 study in Pain Medicine.
The challenge is to immobilize fractured ribs in a way that allows for regular breathing without pain. For patients with a single broken rib, that traditionally has meant being sent home with six weeks of pain medication and often having to sleep sitting up to avoid jarring the edges of the fracture.
“If you do any kind of manual labor, you’re likely to be out of work for nearly two months,” Dr. Mackay says. Those with multiple broken ribs often endure a long stint on a ventilator to maintain positive pressure on the lungs, or they spend an extended period in the ICU.
The group seeking an alternative solution to comorbidities stemming from rib fractures — a group that now included Drs. Dillon, Mackay and Haluck and biomedical engineer Barry Fell — speculated that to avoid making a large incision, minimally invasive surgery could be performed inside the chest cavity, on the underside of the ribs. Dr. Haluck suggested using a thoracoscope to get a clear, live video feed of the procedure from inside the chest.
The next step was to test the technique with actual hardware. Outside-the-box thinking also guided this process: The surgeons picked up a side of pork ribs and started breaking and repairing bones.
Fell helped them work through the logistics of the mechanical equipment needed to do precise work inside the chest cavity. The equipment had to be small enough to fit through laparoscopic incisions and enable the surgical team to manipulate the screws to affix the plates, leaving the smallest possible surgical footprint.
How It Works
The minimally invasive rib fixation system that resulted from those initial sessions uses three small incisions. In the first, a thoracoscope is inserted to guide the surgery. Then, small incisions on both sides of the fracture allow access for clamps that hold the rib steady while two holes are drilled through the bone. Guide tubes are threaded through the holes and pulled out through the incision where the thoracoscope was inserted.
From that location, a cable with the AdvantageRib implant — a metal plate — is threaded into both guide tubes back through the holes in the rib to the surface of the skin. Once the guide tubes are removed, the surgeon inserts the plate into the thoracoscope incision then pulls on the cable ends from the other two incisions, allowing the plate to be positioned precisely beneath the fracture. Finally, special fasteners are threaded onto each end of the cable and inserted through the skin and into the bone to connect with the plate on the underside of the rib. Hollow screwdrivers are threaded onto each end of the cable to fasten the plate securely. The cable is pulled out, and the incisions are closed. The entire procedure takes about an hour.
On the exterior surface of fixed ribs, the low-profile bolts cause a minimum of irritation to the overlying muscle tissue.
The fixation plate is attached to the inner surface of the rib using fiber optics, very small incisions and a procedure Randy S. Haluck, MD, compares to building a ship in a bottle.
The surgeons’ view, via a fiber-optic camera and a thoracoscope inserted low in the chest, shows the curved ribs, the reddish intercostal muscles between them and a fixation plate being attached to a rib to fix, or stabilize, the rib. After the bolts are secured, the thin cables they were suspended on are withdrawn through a small incision.
Collaboration Is Key
Elements of the final design testify to the expertise of each team member. “It would never have happened with any of us on our own,” Dr. Mackay says. Dr. Dillon, for example, specializes in pediatric surgery, including thoracic surgery and minimally invasive surgery — the latter of which is also an area of specialization for Dr. Haluck. Both Dr. Haluck and Fell previously were involved in developing other medical devices. And Dr. Mackay’s early innovation in repairing rib trauma was key to the team’s quest to enhance the procedure.
“High-end care has to be collaborative,” Dr. Haluck says. “The real cutting edge for innovation is in these intersections, or white space, where we come together.”
Push for Innovation
That opportunity to work across specialties, as well as to teach and conduct original research, attracts physicians to academics, Dr. Mackay says. However, bringing a project such as AdvantageRib to fruition poses bureaucratic and other hurdles that require significant institutional backing to overcome. Medical inventions potentially require grants, contact with venture capitalists, navigation of regulatory processes and other steps well beyond the direct development of the device, Dr. Haluck adds.
“All of these things require support from the top,” says Dr. Haluck, who, along with the other inventors of AdvantageRib, founded a company that is marketing the device.
He credits the Invent Penn State initiative, which nurtures a culture of support in those areas throughout the university, and the Center for Medical Innovation, which provides backing for the College of Medicine. Dr. Dillon added crucial support, as well, through his willingness to cross-pollinate specialties by bringing in MBAs or engineers from elsewhere on campus.
“There’s a tremendous personal reward in translating your ideas into something tangible. I enjoy the team I work with — inventing together and throwing ideas around.”
— Randy S. Haluck, MD, chief of the Division of Minimally Invasive and Bariatric Surgery at Penn State Health Milton S. Hershey Medical Center
The first surgery with AdvantageRib was in 2017, and FDA clearance was relatively quick, partly because the materials used in the operation were already approved.
Drs. Haluck and Mackay have traveled to other hospitals to train surgeons in the procedure, and several surgeons have visited the Hershey campus to train on cadavers. Because they also are investors in SIG Medical, team members have deliberately limited their own involvement in surgeries to maintain a high standard of ethics.
“I haven’t been involved in treating any patients myself in the new technique,” Dr. Mackay says. “It’s important that other people take this idea and show its value.”
“It’s an incredible effort to go from zero to one procedure,” Dr. Haluck says. “Now, we’re right around 20. When we get to about 100, things are going to start taking off.”
The inventors believe outcomes data will demonstrate that AdvantageRib’s ability to keep broken ends of ribs from grinding together speeds recovery and reduces the length of hospital stays and need for medication.
“The better and more closely the ribs are aligned, the better they heal; the less motion relative to one another, the less pain,” Dr. Haluck says.
He anticipates that rather than addressing only the sickest patients, which is the current practice, this minimally invasive surgery will be used on a broader range of patients with multiple rib fractures.
Dr. Mackay is equally optimistic. Because of the small surgical footprint of AdvantageRib, he believes eventually there will be an indication for fixing single ribs.
“Patients won’t require the same level of painkillers,” he says. “We’ll certainly decrease that and get patients back to work sooner.”