Mar. 1, 2001 CLEVELAND -- Physicians at University Hospitals of Cleveland, working with biomedical engineers at Case Western Reserve University, have successfully developed a new breathing system that allows spinal cord injured patients to breathe on their own, without a ventilator. Thirty-six-year-old Tom Conlan of Medina, Ohio, has become the first person in the world to receive this breakthrough breathing device, which was surgically implanted in an outpatient procedure using minimally invasive surgical techniques. Working through a laparascope, surgeons placed electrodes in Conlan’s diaphragm muscle. The electrodes, attached to a small battery pack, stimulate the muscle and the phrenic nerve to cause normal inhalation and exhalation. The contraction of the diaphragm muscle accounts for 70% to 80% of the air that inflates the lungs during quiet breathing.
Conlan injured his spinal cord in a swimming accident in July, 1998. Playing with his girlfriend’s children, he leaped into an above-ground pool, and severely injured his neck, damaging the upper part of his spinal cord (at the C2 level). He was comatose for several weeks, eventually waking up to find himself paralyzed, a quadriplegic dependent on a ventilator to breathe. Conlan often compares himself to Christopher Reeve, the actor who also injured the upper part of his spine when thrown from a horse, and who has drawn international attention to spinal cord injuries.
Both Conlan and Reeve depend on the same kind of ventilator to mechanically pump air into their lungs. They can only speak when the machine is pumping air into the lungs and air is moving past the vocal cords (the inspiration phase), a period of time that is less than two seconds in duration. That is why speech is so halted and unnatural.
When Conlan is off the ventilator and on the pacing device, he speaks normally, while his lungs are exhaling air, giving him much more time to speak and a more normal and expressive speech pattern. "I love that I don’t have to wait for the darn vent to give me a breath," says Conlan. "With the pacing device, I can continue to talk just like a normal person would. It is quite the difference, quite the difference."
Conlan also appreciates not having tubing protruding from his throat and attached to a large machine. He says this has allowed him to participate in more aggressive physical therapy to rehabilitate his muscles.
This low-risk, cost-effective, outpatient diaphragm pacing system is a significant improvement over previous attempts to electrically activate the diaphragm. Over the past 25 years, surgeons have opened the chest (thoracotomy) to put electrodes in direct contact with the phrenic nerve, a risky procedure that requires a lengthy hospital stay, and potentially difficult recovery. This procedure costs more than $100,000, whereas the laparoscopic surgery and implantation of the new device cost under $10,000.
Researchers believe that 400 to 500 people each year who suffer spinal cord injuries could benefit from the new pacing device. The long-term hope is that injured patients would be implanted with the device shortly after the spinal cord is damaged, before the diaphragm muscle begins to atrophy. Although there are 10,000 new cases of spinal cord injury each year, only a small percentage involve upper spinal fractures and require long-term mechanical ventilation, like Tom Conlan and Christopher Reeve.
Raymond Onders, MD, a surgeon at University Hospitals of Cleveland specializing in minimally invasive techniques and assistant professor of surgery at CWRU, received FDA (Food and Drug Administration) and IRB (Institutional Review Board) approval before implanting the device in Tom Conlan last year. He will present the impressive results of this surgery at a medical conference in April, 2001.
Dr. Onders worked closely with a team of physicians and engineers, including Tom Stellato, MD, chief of the division of general surgery at University Hospitals of Cleveland; Anthony DiMarco, MD, pulmonologist at University Hospitals of Cleveland and professor of medicine at CWRU; and J. Thomas Mortimer, PhD, professor of biomedical engineering at CWRU, who has devoted more than 20 years of research to electrically activating the nervous system. Some of the components in the pacing device implanted in Tom Conlan were produced by Mortimer’s company, Axon Engineering Inc. of Garfield Heights, Ohio. Other components were produced in the biomedical engineering department at CWRU.
The development and successful implantation of this pacing device was a team effort by researchers and physicians at UHC, CWRU, MetroHealth Medical Center and the VA Medical Center in Cleveland. Funding assistance was provided by U.S Surgical Corporation, UHC, the VA, and the FDA.
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