Greg Gordon, M.D., looks like a radiologist on fire with the flaming apron he wears at work at the Omaha VA Medical Center.
Dr. Gordon’s garment doesn’t make him hot, but the 30 pounds of lead lining does weigh him down. The lead that shields him from continuous X-ray radiation exposure literally causes pain in his back.
As an interventional radiologist, he uses fluoroscopy X-rays, CT, ultrasound, MRI and other minimally invasive image-guided procedures to diagnose and treat diseases in nearly every organ system.
“Basically, I’m a surgeon who doesn’t cut anyone open. I look through people using X-ray movies to open blood clots, put in stents. We’re vascular plumbers and carpenters,” Dr. Gordon said.
He is proud to be part of the exciting field of interventional radiology (IR). For the past 30 years, interventional radiologists have been responsible for much of the medical innovation and development of such minimally invasive procedures as angioplasty and catheter-delivered stents that are commonplace today.
His pains come from the apron, but also from the X-rays he has continuously used to inject dyes and clear arterial blockages in patients for the past 20 years. It’s not uncommon for him to wear the vest for up to 12 hours each day while leaning over multiple patients daily – 2,000 a year – with his hands and the left side of his body exposed to radiation.
“I sometimes get home and I can’t walk. I can’t move.”
Fortunately, Dr. Gordon, research associate professor, UNMC Internal Medicine, is a clever man who has designed two devices that he hopes will cure his pains, and the pains others like him endure.
Body stress, strain and injuries are common issues. Up to 75 percent of interventional cardiologists complain about spinal problems, according to a 1997 study conducted by the American College of Cardiology. Similar results have been replicated in a recent Society of Interventional Radiology study from 2015. These injuries are caused by the leaded protection IR physicians wear while standing in awkward positions and angles.
Dr. Gordon has had two hip procedures to fix the damage caused by the lead apron and will need another within the year.
“My skill sets go down because of the pain and stress,” he said. “It is difficult to maintain the steady hand that I need.”
Besides bodily stress, cancers and tumors are another risk from IR procedures. Working closely with X-ray radiation for extended periods cumulatively increases the chance of developing health problems such as cataracts, premature vascular disease, lymphoma, breast cancer and central nervous system tumors, even when wearing protective garments.
According to a recent study from Israel, interventionalists (radiology, cardiology and vascular surgery) are three times more likely to die from left-sided versus right-sided brain cancers. Additional cumulative data suggest continuous low dose radiation risk may have an additional risk between 1 and 2.5 percent risk of cancer for the average interventionalist versus physicians who do not use radiation.
Three years ago when he was just 46, Dr. Gordon himself was diagnosed with the early formation of cataracts.
Current radiation safety standards are based on 1950s data with minimal revisions since, and the Radiation Protection guidelines (ALARA: As Low As Reasonably Achievable) were first adopted in the 1990s. In the interval, European guidelines have become much more stringent with a decrease in whole body exposure by 60 percent and a significant decrease in eye exposure. U.S. guidelines are due to follow soon and more stringent guidelines can mean loss of physician privileges in the interventional suite.
There are three rules when dealing with radiation safety – time, distance and shielding. There have been few improvements in the health and safety for IR employees despite the risks, Dr. Gordon said. Attention is growing, however, and monthly position statements discuss the need for improved working environments.
So, necessity was the mother of Dr. Gordon’s inventions, which were built around his 2012 start-up company, Radux Devices. UNeMed, the technology transfer office for UNMC, helped him license six patents and launch Radux. A recent $250,000 proof-of-concept grant from the university’s Nebraska Research Initiative has given him the chance to develop and test working prototypes of his flexible sheath and radiation shield.
The Lock-Block is a portable shield that allows the physician to work close to the patient, when need requires, while simultaneously decreasing his exposure by 50 to 85 percent. The portable radiation shield, about the size of a steno notebook, blocks X-ray radiation from the physician’s hands and body. It also helps the IR gain control of the surgical area, and allows the physician to stand in a more ergonomically friendly position versus standard portable shielding.
The shield weighs six ounces and is made of a plastic polyethylene and barium sulfate polymer that blocks and absorbs “scatter” radiation that escapes between the patient and the machine. It is disposable and costs around $60, but Dr. Gordon says his long-term “green” plan is to manufacture shields in different sizes that can be sterilized, with only the pads being disposable.
The R2Flex is an attachable extension support sheath that is designed to work alone or with the Lock-Block. The 8-inch long, Teflon coated plastic polymer sheath, reinforced with a stainless steel coil, attaches to a standard vascular access sheath which is secured to the patient with a clip. This allows the IR to work farther away from the radiation field – decreasing the radiation dose by 50 percent.
The R2Flex simultaneously allows improvement in guiding diagnostic and therapeutic devices into the patient’s blood vessels with less muscle fatigue demonstrated in proof of concept studies. It is universal in design and can adapt to most sheaths on the market.
The two devices, which can be used together or separately, redirect the workflow back to the IR and add stability to the sheath and improve access site management, where wires can sometimes be up to 10 feet long. The final results from ergonomic studies are pending, but less muscle fatigue has been noted, Dr. Gordon said.
Before the devices can go on the medical market, they need FDA approval and studies proving their effectiveness. Dr. Gordon said animal studies have found a 50 percent reduction in radiation for one shield and an 85 percent reduction if two shields are used at the same time. Next will be human trials.
Building a company from the ground up has been an incredible learning experience. “I was so naïve,” Dr. Gordon said. To counter his lack of knowledge, he is surrounding himself with people who know how to take an invention to the marketplace.
He recently signed on former Nebraskan Richard Ganz, now executive-in-residence at the University of Chicago Office of Technology and Intellectual Property, as CEO, and Laura Classen, executive director of Nebraska Angels, as CFO.
The prototypes are now made in Utah, but Dr. Gordon said it would be ideal if they were manufactured in Nebraska.