#Innovate4Health: Peruvian “Bubble” Gives High-risk Newborns a Fighting Chance

By Jaci Arthur

This post is one of a series in the #Innovate4Health policy research initiative.

Helping high-risk babies survive their early days is one of the world’s biggest health challenges. In 2017 alone, approximately 2.5 million children died in their first month.

Now, these most vulnerable of infants have been given a fighting chance, thanks to a university team in Peru. Led by inventor Claudio Bruno Castillano Levano, the team has invented a new portable incubator with a respirator, known as the Incuven. Crucially for an effective global solution to a large and escalating healthcare problem, the Incuven is ideal for use in developing countries.

Levano with the neonatal artificial bubble.

Fifteen million children worldwide are born prematurely each year. Add to these the countless other high-risk newborns with illnesses, infections, birth asphyxia, and other problems whose first hours are perilous, and about 1 million infants each year do not survive their first 24 hours.

The World Health Organization’s (WHO) 2012 Global Action Report on Preterm Birth indicated that 8.6 percent of all births in Latin America in 2010 were preterm. Latin America and the Caribbean accounted for approximately 4 percent of the world’s neonatal deaths in 2017, with an estimated 102,522 newborn deaths across the region.

This heartbreaking loss is felt beyond infancy too. WHO reports that complications from preterm birth are the leading cause of death among children under five years old. Moreover, preterm babies are at a higher risk for lifelong disabilities.

The majority of these deaths and complications are preventable, often by relatively simple interventions. Even without intensive care, up to 75 percent of neonatal deaths resulting from preterm birth can be prevented simply by keeping the newborn warm, ensuring careful hygiene, and regulating oxygen and breathing.

As a solution to these problems, the baby incubator has a long history. The first, developed in France in 1880, was an attempt to boost a low population growth rate after the Franco-Prussian war and prolonged famine. Traditionally, incubators are expensive, large, immobile and reliant on a reliable power supply, which is rarely a problem for the sophisticated, well-equipped hospitals in developed countries, but much more commonly a challenge in developing nations. That explains why, as one WHO report reveals, it’s developing countries with the lowest access to healthcare where most newborn deaths occur.

Undeterred, Levano, an engineer, and his team at the Pontifical Catholic University of Peru, set their innovative sights on building an incubator more adaptable for diverse environments. A decade later, the Group of Research and Development of Medical Equipment and Systems (GIDEMS) developed Incuven.

GIDEMS and Levano were working to develop medical equipment in Peru when they came up with what they call the “neonatal artificial bubble.” They found existing solutions weren’t fully suited to Peru and other countries with the biggest neonatal health problems. Trying to copy pre-existing equipment would also keep Peru lagging behind the rest of the world in medical technology. So, Levano and his team took on the challenge differently.

And how they delivered. Unlike its predecessors, Levano’s neonatal artificial bubble stabilizes temperature, reduces fan noise, and significantly reduces the risk of contamination.

From US patent 6884211

The device is capable of providing fast and simultaneous thermal and pneumatic therapy to newborns. In less than two seconds, the bubble envelops the newborn in a warm, oxygen-enriched and sterile environment, making it an ideal haven for preterm babies at risk of hypothermia, hypoxia, and infection or sepsis. The humidity never threatens sterility as the device minimizes the amount of condensation settling in corrugated areas. Medical personnel also benefit from quick access to the newborn in cases of surgery or intubation.

Incuven is the latest of seven prototypes produced by the GIDEMS team over the years, each an improvement on the last. This innovation evolution has made Incuven ideal for more challenging environments in developing countries.

Now, GIDEMS is ready to commercialize Incuven. It has successfully completed pre-clinical trials and will soon start clinical trials to satisfy international standards and prove its reliability.

Incuven will be invaluable to environments where the need for easy-to-use incubators is most urgent. It is easy to handle and move and works with a battery, important where power supplies are less reliable. Limited resources are no barrier either. It’s designed to be used in hospitals or care centers that lack neonatology specialists or that do not have intensive care units, as is the case in much of the world. Incuven is set to make a big impact.

Patents have been the stepping stones for Incuven’s 20-year research and development journey. They have preserved the investment and hard work of Levano and his team.

Levano’s neonatal artificial bubble is protected by several patents around the world, including U.S. patent 6884211 and Peru patent PE000622–2002 / OIN and the team will seek to secure other patent rights soon. While Levano is credited as an inventor, most of these patents are owned by Pontifical Catholic University of Peru (PUCP).

Levano says ongoing support for his and GIDEMS’ work from PUCP has been crucial, as there is scant support for research in Peru. Patents have the potential to turn such precious support into a mutually beneficial, virtuous circle. The patents on Incuven serve as a bridge between university-funded research and commercialization. The university can recover its costs and acquire funding for continued research and development. The researcher can gain personally and professionally.

In this way, the successful path being followed by PUCP and Levano is the same forged by countless universities in the U.S. and other developed countries.

Levano’s is just one of the numerous cases of innovation that can flourish with such a relationship to produce extraordinary results and improve lives across the globe.

Levano and GIDEMS have devoted two decades to addressing the global health challenge of saving infant lives. They have also shown the way for future innovation in Peru, with patents as the catalyst to success in the marketplace.

#Innovate4Health is a joint research project by the Geneva Network and the Information Technology & Innovation Foundation (ITIF). This project highlights how intellectual property-driven innovation can address global health challenges. If you have questions, comments, or a suggestion for a story we should highlight, we’d love to hear from you. Please contact Stephen Ezell at sezell@itif.org.