Hopkins undergraduate biomedical engineering design teams never cease to amaze with their innovative and practical medical inventions. Past teams have devised devices such as CervoCheck, a labor monitoring device for pregnant women. This time, a BME design team has wowed the Hopkins community once again by inventing a novel device called the “Cooling Cure,” which could potentially save the lives of millions of newborn babies with Hypoxic Ischemic Encephalopathy (HIE).
HIE is a condition that deprives the newborn baby’s brain of oxygen, which, if not treated within six hours of birth, often causes brain damage, neurological diseases like cerebral palsy or even death. Risk factors that lead to oxygen deficiency in the brain include umbilical cord knotting, placenta problems and untrained delivery.
The good news is that prolonged cooling of an HIE-affected baby immediately after birth can be a therapeutic strategy to prevent the ensuing brain damage. However, unfortunately, the expensive, high-tech medical equipment required for such treatment is often unsuitable for developing nations, and pregnant women in impoverished regions often lack prompt access to medical specialists or high-tech hospital equipment. As a result, neurological complications and infant mortality caused by HIE are much more prevalent in developing nations.
The Cooling Cure, a cheap, medical device designed by a team of undergraduate students studying biomedical engineering, effectively lowers the body temperatures of newborn babies suffering from HIE in order to prevent irreversible brain damage and ultimately save infant lives.
The current standard of treatment in the United States for HIE is therapeutic hypothermia, in which the body temperature of an infant is lowered on a cooling blanket to 92 degrees Fahrenheit and maintained at that temperature for three days. After this hypothermic period, the baby is rewarmed at a gradual rate of 0.9 degrees Fahrenheit per hour until his or her core body temperature reaches 97.7 degrees Fahrenheit. Unfortunately, the use of this treatment is not viable in developing nations since the current advanced hypothermia devices are expensive and require large amounts of electricity.
The Hopkins student team’s low-tech baby-cooling device is simple enough to be utilized in developing nations without supplemental, standard therapeutic hypothermia treatments or reliable electrical infrastructure. The total cost of the device is less than 40 dollars, which is 99 percent lower than current advanced hypothermia devices.
“My team was amazed that so many millions of babies in developing countries suffer from the impacts of a disease that can be so easily treated in the United States,” John Kim, leader of the student team and a post-graduate from Santa Barbara, California, wrote in an email to The News-Letter.
“We believe that making a cost-effective cooling device available for developing countries can bring a significant impact by saving lives of innocent newborns suffering due to the lack of resources and health systems,” he wrote.
Cooling Cure consists of basic electronics, two clay pots, sand and urea-based instant cold pack powder. Sand is placed inside the larger clay pot and is mixed with the urea powder. The smaller clay pot is then placed on top of the sand, and the newborn is placed inside. To cool the newborn, water is added to the mixture of sand and powder, causing a chemical reaction that draws heat away from the newborn. To rewarm the baby, a small block is placed inside the pot underneath the child. Additional blocks can be added to increase the warming rate.
The entire baby-cooling device is monitored by a microprocessor and sensors that detect skin and rectal temperature. Two sets of LED lights on the device indicate the status of the neonate’s treatment. One set of LED lights, attached to the skin and rectal monitoring sensors, provides temperature feedback and assists in obtaining the specific ranges within which the neonate’s body temperature must be kept during cooling and rewarming. Nurses or family members can add more water to the sand if the baby is too warm or lift the baby away from the cooling surface if the baby is too cold.
The other set of LED lights, located on the side of the outer pot, corresponds to three different heights at which the baby may be elevated or lowered to achieve an optimal rate of cooling or rewarming. The monitoring system is powered by two AAA batteries.
The cooling method that the team implemented in their invention is based off of a simple, historical cooling method.
“Our greatest success is … turning a simple technique for refrigerating food used since ancient times … into a controllable and efficient method to prevent brain damage in newborns,” Kim wrote.
The team tested their device using piglets, under the guidance of the Hopkins School of Medicine’s pediatric critical care unit laboratory and the neonatal neuro-intensive care nursery with the approval of the Hopkins Animal Care and Use Committee. The anatomy and stages of neuronal development are similar in piglets and human neonates, making the animals an optimal choice of model.
Nevertheless, there are some differences between using the device on piglet models and on actual human newborns.
“A major difference between the two is that significantly more care must be shown to avoid any side effects that would impact the long-term health of a baby,” Kim wrote. “While the piglets were specifically obtained for this short-term study of the cooling ability of the device, the newborns are undergoing this treatment in hopes of preventing serious neurological disease that will impact their entire lives.”
There were other challenges throughout the development of the Cooling Cure. In order for the device to be effectively implemented in developing nations, it could not rely heavily on electricity. Additionally, the device had to be able to lower and raise the newborn’s body temperature by precise amounts at optimal rates within specific periods of time.
“One of the big challenges was how to cool newborns for three days without using too much electricity,” Kim wrote. “Not only did the cooling have to achieve a certain temperature, but also it had to cool at a specific rate; not too quickly, and not too slowly. In the beginning, we tried different methods for cooling, but they were not cost effective or efficient.”
The Cooling Cure device exemplifies one of the fundamental values of biomedical engineering — the patient’s needs come first.
“This device shows two of the key elements of biomedical engineering: understanding the core physiological and physical elements of a medical process and the associated technologies, and using that knowledge to engineer a device that fits well within the target market,” Kim wrote.
“These two ideas, the core sciences and the end-goal understanding, are key to biomedical engineering because of the patient-centric viewpoint that all projects start from and end at,” he wrote.
The Cooling Cure device also opens up new doors in advancing biomedical engineering developments and patient care.
“This device provides an excellent example that other engineers and researchers can follow in regards to breaking down current sophisticated technology and designing simpler devices that can change the world,” Kim wrote.
“It further stresses the importance of understanding the environment in which the device or research is being applied, and making use of simple materials and methods within those surroundings to create a product that fits well with the consumers that will be using it.”
With the help of the Cooling Cure device, many newborn babies in developing nations may be saved from a fatal disease and given a second chance at life.
