May 4, 2008 A University of Rhode Island biomedical engineering professor has launched a company to market a unique system he co-invented that rapidly reduces one’s body temperature in emergency situations to aid in recovering from heart attacks and other serious illnesses.
William Ohley, who has taught in the URI College of Engineering for 28 years, joined with medical colleagues in Louisiana and New Jersey to form Life Recovery Systems after developing what they call the Thermosuit® , a plastic suit that encases unconscious patients to flood their bodies with cold water to induce hypothermia.
“Just 10 to 20 percent of cardiac arrest patients whose hearts are restarted recover fully, primarily because the lack of blood flow to the brain causes brain damage or brain swelling,” Ohley explained. “But if doctors can rapidly induce hypothermia and reduce the patient’s body temperature by three to five degrees Centigrade, their chances of a full recovery are significantly greater.”
Ohley said that it has long been understood that “being cold is good for the brain and the heart,” pointing to the many examples of individuals who are revived after nearly drowning in icy lakes, even when they were unconscious and under water for 30 minutes or more.
The challenge, he said, has been to create similar hypothermic conditions in emergency situations in hospital settings and elsewhere. Systems have been developed that blow cold air over the body or deploy ice packs, but they often take hours to reduce the body temperature to effective levels. Ohley’s system takes just 30 minutes.
Since 2001, Ohley has received $1.25 million in funding from the National Institutes of Health through its Small Business Innovation Research grants program to develop and test the device. Laboratory experiments were conducted on pigs at the University of Rhode Island in 2002 and 2003, and limited clinical trials on humans were conducted in 2005 and 2006. The Food and Drug Administration granted a 510K to allow marketing the suit as a cooling system in 2006.
The device is now being deployed in a number of hospitals around the country and internationally, and nursing and emergency room staff are being trained in its use. Hospitals using the suit report that the survival rate of patients suffering cardiac arrests has risen from 35 percent to 60 to 70 percent.
“We know that many people have already been rescued by it,” Ohley said.
Additional trials are planned at Rhode Island Hospital and elsewhere to examine its effectiveness for patients with acute myocardial infarctions or post resuscitative syndrome, the latter of which occurs when a patient’s heart has been restarted but they haven’t woken up yet. Ohley believes that stroke patients and those with brain and spinal cord injuries may also benefit from its use.
The American Heart Association’s patient care guidelines indicate that the body temperature of cardiac arrest patients should be reduced to 32-34 degrees Centigrade and held there for 12 to 24 hours.
“The speed of the cooling is particularly important,” said Ohley. “No one else makes a device that does it as quickly as our Thermosuit.”
To conduct further clinical studies and continue marketing the device, Ohley and colleagues are seeking additional grant funding and outside investors
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