The Titanium Rib Project
There comes a time in everybody’s life when they’re faced with a choice: either step up to the plate and take a swing against all odds—go for the home run—or play it safe. Maybe not even get off the bench.
Doctors, and especially orthopaedic surgeons, find themselves in this situation time and again. That doesn’t make it any easier, however, especially when a fragile child’s life is at stake. Should you take a risk, even though convention or standard practice excuses you from doing so?
And even more to the point, if you choose to go for it, how do you save such a life when the tool you need doesn’t even exist? When you’re Robert Campbell, MD, of Christus Santa Rosa Children’s Hospital in San Antonio, Texas, you invent it. In this case, the “it” is the world’s first vertical, expandable prosthetic rib.
Seven of the twelve ribs simply weren’t there, so there was no support for the lung and he was ventilator dependent. The child also had severe scoliosis. Doctors in Houston had tried to treat the chest wall defect with a splint, but had been unsuccessful. In Dr. Campbell’s words, “out of options, the child was sent home to die.”
Dr. Campbell was sitting in the hospital’s fifth floor operating room when Dr. Melvin Smith, a pediatric general surgeon in charge of the boy’s case, approached him with the patient’s x-rays, wondering if they could rig up a chest wall of some sort to save his life.
“I didn’t know it at the time, but I was about the third orthopod Dr. Smith had asked and the other two had said sorry, but there’s nothing to be done,” Dr. Campbell recalls with a slight smile. While that may be true, Dr. Smith remembers he was just trying to find assistance from “somebody who had as wild ideas as I did.”
Dr. Smith suggested using some plates or rods that could be screwed into place, but any screws used around the chest would work loose and perhaps go into the heart. They were going to have to come up with something new.
Dr. Campbell went home that night and, after a bit of doodling, settled on using fracture pins—metal pins used to stabilize and realign broken bones. The only problem was which way to run them. “If you put them sideways, you’re hooking them to the spine and to the sternum,” Dr. Campbell explains. “If it tears out in front, it’s going to go into the heart. Tears out in back, it’s going into the spinal cord. Both unacceptable…but if you did something that was fairly crazy but logical—put them vertically—then it would work.”
It was one thing to make some doodles but quite another to make those doodles real—inside a sick infant’s chest.
“When Dr. Smith made the skin incision, he was almost on lung. There was nothing there,” Dr. Campbell remembers. “I stuck the first Steinmann pin up there, got sterile vice grips, and started bending them around the ribs of this six-month-old infant. It was just terrible because I had to use tremendous force. One slip and I would have torn the axillary artery or damaged the spinal cord…my shoes were filling up with sweat.”
Even more extraordinary, post-op x-rays revealed that they had indirectly corrected the boy’s scoliosis without going anywhere near the spine. Four days later, he was off the ventilator for the first time since being born.
They had saved his life.
The euphoria, though, wore off within a few months. The pins wouldn’t grow as the boy matured, and therefore the makeshift device would end up harming the patient: the lung wouldn’t grow and the scoliosis would return. Dr. Campbell decided he had to develop a new device to replace the Steinmann pins. “I had no idea what we were going to do, but I just knew something had to be done. You know how necessity is the mother of invention? Well, necessity was the life or death of this child.”
Dr. Campbell decided to approach a large orthopaedic manufacturing company about making a device that could replace the fracture pins—something that would work more long term. After two months of negotiating with the first company he contacted, he hadn’t even gotten past the confidentiality agreement. “I realized I needed to search for a company that not only had the resources to do this, but also the heart,” explains Dr. Campbell.
The second company he approached, a smaller firm, contacted him about a month later saying they couldn’t do it but referred him to a custom prosthesis firm in California called Techmedica that had a good reputation for turning things around quickly. They scheduled a meeting for the fall of 1988—a year after the initial surgery. The patient was doing well, growing, putting on weight, but the long-term problem was evident. Some of the curvature was returning to his spine. He needed a new device for his chest—something that could be easily implanted and expanded periodically for growth.
While on vacation before the meeting, he sketched designs on his children’s construction paper, and after a few hours he had designed the world’s first expandable rib. When the date for his meeting with Techmedica approached, and putting a truncated engineering education to good use, he turned his sketches into an actual blueprint—something a manufacturing company could use. What he came up with was simple but ingenious. The rib would be made like a curtain rod but curved to give volume for the lung. When it needed to be expanded, it could be done with very small incisions during outpatient surgery.
Dr. Campbell answered, “Maybe two or three.”
The CEO paused for a long while and finally said, “Well, we’re still going to do it.” All Dr. Campbell had to do was agree to hold a press conference afterward to help drum up a little publicity for the company.
For the next half year, Dr. Campbell and the engineers at Techmedica traded blueprints back and forth and eventually a prototype was made, but it was too weak when completely expanded. Dr. Campbell convinced them to try a new last-minute approach, but time was running short for the patient. He was still healthy, but his spine was getting worse and the operation needed to happen soon. Eventually, Drs. Campbell and Smith scheduled the surgery for April 19, 1989, therefore establishing a date for the titanium rib to be finished (they’d chosen titanium because it is lightweight, biocompatible and noninterfering with MRI scans).
The ribs arrived the night before surgery on an eight o’clock commercial flight; no time for anything except getting a good night’s sleep and taking the untested mechanical ribs to the hospital.
The surgery went remarkably well. The titanium ribs (or VEPTR, as they are now called, for Vertical Expandable Prosthetic Titanium Rib) worked as planned, although Dr. Campbell did have some troubles with the first rib: “I didn’t know much about working with titanium at the time. I was bending the loops with vice-grips. I bent them into place. Didn’t look right so I bent them back. Then I bent them again. It didn’t look right so I bent them again and they broke off. So, okay, don’t bend them a lot… I was real careful with number two.” A few hours later, the child was in the recovery room.
Within a month, the patient was doing well and he and Dr. Smith held a press conference to announce the ribs’ success—as promised to Techmedica. They got a lot of attention—too much! Soon, parents from all over the country were calling them to fix their childrens’ thoracic deformities.
Dr. Campbell and Dr. Smith formed the Titanium Rib Project and started to do more surgeries to help children with similar problems. They named the disease of these children “thoracic insufficiency syndrome.” Six new operations, made possible by the VEPTR, were developed.
Although not required, Dr. Campbell briefed the Institutional Review Board (IRB) at his hospital before each early surgery, but by the third, a nun on the IRB said she understood FDA rules on custom medical devices and she wondered how this new rib made by Techmedica was any different than the last one (as long as a prosthetic device is a custom design—meaning for a single, particular purpose, no FDA approval is needed). Dr. Campbell labored to explain that this was a different device because “it was longer” than the last one, but when the nun responded with a knowing look, he knew she had a point. Soon afterwards, he started the process for getting FDA approval, and 17 years after bending those first pins around the dying six-month old boy, the VEPTR, now manufactured by Synthes, received FDA approval in August 2004.
The VEPTR, a modern success story of not only pediatric orthopaedic engineering but also of caring determination, is currently used in 26 countries worldwide and has saved hundreds of lives. And that infant boy originally sent to San Antonio to die? He’s a 20-year-old man.
It’s a good thing Dr. Campbell and Dr. Smith weren’t afraid to take a swing.
Photo of infant’s x-ray, courtesy Robert M. Campbell Jr., MD
Photo of Robert M. Campbell, Jr., MD, and Melvin Smith, MD, courtesy Robert M. Campbell, Jr., MD
Photo of pediatric patient, courtesy Robert M. Campbell, Jr., MD
Photo of rib prosthesis, courtesy Robert M. Campbell, Jr., MD
Photo of pediatric patient x-ray postsurgery, courtesy Robert M. Campbell, Jr., MD
Titanium Rib designs, courtesy Robert M. Campbell, Jr., MD
Photo of Titanium Rib, courtesy Synthes