May 15, 2001 CLEVELAND -- With the help of researchers and physicians from Case Western Reserve University and University Hospitals of Cleveland, Tom Conlan can take a breath and smell. For most of us, that doesn't seem like a big deal, but Conlan is paralyzed from the neck down and cannot breath without help.
For people in his condition, that help comes from a ventilator, a mechanical pump that connects into the throat with a plastic hose. The ventilator fills his lungs with air, bypassing the mouth and nose and depriving him of the sense of smell. And he breathes when the machine forces him to take a breath.
Conlan, 36, of Valley City, Ohio, is now the first person in the world to have a revolutionary electrical stimulation device that activates the phrenic nerve in his diaphragm, the large breathing muscle. The device gets him off the ventilator and allows him to breathe through his nose and mouth. Now a small pleasure that most of us take for granted is a major change for him.
"I can smell everything," he said.
The device was developed from 20 years of research in electrical stimulation of muscles in the laboratory of Thomas Mortimer, professor of biomedical engineering at CWRU. Mortimer and his colleagues also developed computer software to map the nerves in the diaphragm, essential to putting the electrodes in the correct spots.
The device was implanted last March in a minimally invasive surgical procedure led at UHC by Raymond Onders, a CWRU assistant professor of surgery. Working through a laparascope, Onders placed electrodes in Conlan's diaphragm. Conlan's medical team also includes Tom Stellato, CWRU professor of surgery and UHC chief of general surgery, and Anthony DiMarco, CWRU professor of medicine and UHC pulmonologist.
The development of the electrical stimulation device was a team effort by biomedical engineers and physician-researchers at CWRU, the Louis Stokes Cleveland VA Medical Center, UHC, and MetroHealth Medical Center.
DiMarco thanked Conlan for his bravery in volunteering to be the first person to use the device. Conlan said his primary care physician advised him against the procedure, fearing damage to the phrenic nerve, which carries signals from the brain to the diaphragm. Conlan's feeling was, "What do I have to lose?"
Direct stimulation of the phrenic nerve can harm it. Complicating the procedure is that the phrenic nerve cannot be seen. In the new procedure, the electrodes were placed in the motor points on the diaphragm to stimulate the nerve without direct contact. This involved using the science of computers to find those points and the art of surgery to place the electrodes in the right places.
The electrical stimulation device, which is powered by batteries that are changed weekly, has made his daily life easier. When Conlan is off the ventilator and on the stimulation device, he speaks normally, while his lungs are exhaling air. This gives him much more time to speak and a more normal and expressive speech pattern.
This is in contrast to life on the ventilator, which allows him to speak only when air makes a trip across his vocal cords while it is being pumped into his lungs.
"I love that I don't have to wait for the darn vent to give me a breath," said Conlan. "With the pacing device, I can continue to talk just like a normal person would. It is quite the difference, quite the difference."
However, he is not totally free of the ventilator. According to the physicians, his diaphragm is out of condition. It is a muscle that was not used at all for two years after the July 1998 swimming accident which left him paralyzed.
While playing with his girlfriend's children, he jumped into an above-ground pool and severely injured his neck. He damaged the upper part of his spinal cord. When he awoke from a coma weeks later, he was a quadriplegic, dependent on the ventilator. He said there are many days when he asks, "Why me? What did I do in life to deserve this?"
This low-risk, cost-effective, outpatient diaphragm pacing system marks a significant improvement over previous attempts to electrically activate the diaphragm. During the past 25 years, surgeons have opened the chest to put electrodes in direct contact with the phrenic nerve. That procedure is risky, requires a long hospital stay and potentially difficult recovery, and costs more than $100,000. In contrast, the new approach costs less than $10,000 and only requires small incisions to allow access to the diaphragm with a laparoscope.
Researchers believe that 400 to 500 people each year who suffer spinal cord injuries could benefit from the new device. DiMarco said he hopes that in the long-term future, injured patients would be implanted with the device 48 to 72 hours after injury, before the diaphragm muscle begins to atrophy. Although there are 10,000 new cases of spinal cord injury annually, only a small percentage involve upper spinal fractures and require long-term mechanical ventilation, as in Conlan's case, or as in the case of actor Christopher Reeve, who is best known for his portrayal of Superman in the movies and who was injured in a horse riding accident.
The next step is to recruit five more patients to complete the study at UHC. It is funded for $300,000 over three years by the Orphan Product Program of the U.S. Food and Drug Administration. Some of the components in the pacing device were produced by Mortimer's company, Axon Engineering Inc. of Garfield Heights. Other components were produced in the Department of Biomedical Engineering at CWRU. Funding assistance was provided by U.S. Surgical Corp., UHC, and the VA, in addition to the FDA.
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