The Press-Dispatch
Issue link: https://www.ifoldsflip.com/i/1386251
A-8 Wednesday, June 23, 2021 The Press-Dispatch Every newborn on a ventilator can now be better protected By Kayla Wiles Purdue News Service wiles5@purdue.edu If a newborn is moved or be- comes agitated while on a ven- tilator, the breathing tube also could move. Just a few seconds with the tube in the wrong posi- tion might lead to a critical lack of oxygen to the brain, possibly resulting in lifelong disability or brain damage or even end- ing the baby's life. The incident is far too com- mon. Unplanned extubation – when a breathing tube acciden- tally becomes dislodged from the trachea – affects 75,000, or about one in five, newborns on ventilators each year, an analysis by Premier Data Ser- vices found. A medical device born out of Purdue University could save these babies' lives by helping to keep their breathing tubes at the correct depth. In 1990, George Wodicka had just started as a professor at Purdue when a local pediat- ric cardiologist came to him de- scribing how the problem was affecting babies and nurses in her hospital. Since 2016, five neonatal intensive care units in the U.S. have been using what Wodicka and his students later invented as a solution: the first and only FDA-approved med- ical device that alerts nurses when a baby's breathing tube is in the wrong position or ob- structed. To make the device avail- able to babies in every NICU, one of the world's largest med- ical technology companies, Medtronic, recently added the Purdue invention to its product line as the SonarMedTM Air- way Monitoring System. The company adopted the technol- ogy through its acquisition of SonarMed Inc. in December, a startup Wodicka co-founded to bring the device to market. Medtronic's extensive mar- ket presence puts the So- narMed airway monitor on its way to becoming the standard of care for all babies requiring breathing assistance. But find- ing a way to get this life-saving solution to babies didn't come without a fight. The device not only required a breakthrough in biomedical acoustics, but also a 30 -year battle against the unfortunate reality that it is much harder to bring new technology to the NICU than it is to the ICU. As of 2020, the global NICU market stood at $1.5 billion, sig- nificantly smaller than the $5.5 billion global adult ICU market. A smaller market size means less investment in the most ad- vanced technology for the tini- est of babies. "The pediatric space is so underserved. I only have one 30 -year project in me – this one was it," said Wodicka, who is now the Dane A. Miller Head of Purdue's Weldon School of Biomedical Engineering, and a professor of both biomedi- cal and electrical and comput- er engineering. "Such future re- search and development efforts need to take a few years, not a few decades, to broadly reach children in need." Minimizing the number of X-rays done on ventilated new- borns Similarly to 30 years ago, NICUs typically use X-rays to check that a breathing tube is in the correct position or to detect a blockage, such as mucus. But it's as easy to accidentally place the tube too deep, which could puncture the baby's bronchus, as it is for the baby to squirm the tube out of the correct po- sition. If the baby's movement af- fects the tube's placement, an X-ray has to be taken all over again – often daily. Each un- planned extubation in pedi- atric patients can lead to hos- pital costs of $ 36,692, a study found, and lengthen a baby's stay in the hospital by more than six days. "These babies were constant- ly having X-rays taken to locate where the tube was placed. And I told George that if we had a way to know where the tube is without taking an X-ray, it would be very good both for the baby to not get all that radi- ation and for the cost," said Bar- bara Bourland, who in 1990 was a pediatric cardiologist at Home Hospital in Lafayette, Indiana. Bourland met Wodicka through her late husband, Joe Bourland, a professor and biomedical en- gineer at Purdue who had re- cruited Wodicka to come to the university. Wodicka's expertise in bio- medical acoustics led him to consider the feasibility of using soundwaves to guide the place- ment of a baby's breathing tube, sparing the baby from an X-ray every time the tube moves out of place or gets blocked. Huntington Hospital in Pasa- dena, California, was the first to use the SonarMed airway mon- itor in its NICU. Since adopting the device in 2016, the NICU's rate of unplanned extubations has dramatically decreased and X-rays almost never have to be taken to check the placement of an endotracheal tube. "We don't want to disrupt the little guys unless we have to. With the SonarMed air- way monitor, we can very eas- ily detect something before it becomes a problem and mini- mize the amount of time that we have to interact with the baby," said Jamie Powers, medical di- rector of the NICU at Hunting- ton Hospital. Shortly after adopting the So- narMed airway monitor, Hun- tington Hospital's NICU was tasked with treating a baby bleeding into her lungs. The device helped the staff identify and adequately suction out the baby's blood clots without caus- ing more trauma to her lungs, allowing the baby to breathe on her own within a day. The long road to continuous- ly monitoring babies' airways through soundwaves What makes the SonarMed airway monitor effective is its revolutionary use of sound- waves that aren't used in oth- er medical devices. Ultrasound waves, the most common use of acoustics in medicine, wouldn't stay within a baby's breathing tube. But the human body is already good at localizing the soundwaves that do. "When I got interested in sound, this was back in the days when people like me built their own stereos and speak- ers," Wodicka said. "Over the years, my research has focused on using sound in novel and cre- ative ways to monitor health and well-being for some unmet clinical need." Creating soundwaves that can stay within a baby's en- dotracheal tube ultimately re- quired building a device with a tiny speaker on one end and two sensing microphones – initial- ly adapted from hearing aids – on the other end. Sound travels from the speaker in the device to the end of the connected en- dotracheal tube. The SonarMed airway monitor software mea- sures the soundwaves that echo back through the micro- phones, informing clinicians on a screen in real time where the tube is located and whether there is an obstruction. Building the initial Purdue prototype took 15 years. Jeff Mansfield, now chief tech- nology officer of SonarMed, was the first graduate student whom Wodicka hired to work on this project. Mansfield spent both his master's and his Ph.D. years developing the technolo- gy – and would continue build- ing multiple prototype itera- tions to create the device that is used in hospitals now. Downsizing technology for the underserved and tiniest of humans In 1997, then-Purdue Ph.D. student Eduardo Juan, who is now a professor of electrical engineering at the University of Puerto Rico at Mayagüez, worked to miniaturize and auto- mate the acoustic guidance sys- tem that Mansfield had started. Juan's research would lay the groundwork for making the device, which had started off bigger than a breadbox, small enough for babies in the NICU. "The system wasn't really clinically feasible at the time. So when I came on to the proj- ect, my job was to actually take everything that Jeff had done so far and make it small," said Juan, who would continue serv- ing on SonarMed's board of di- rectors until the startup's acqui- sition by Medtronic. But first, the researchers would have to test the technol- ogy in adults. The FDA approv- al process for medical devices is less burdensome for adults than for NICU babies, and the technology needed to undergo testing in adults before it could be made even smaller for ba- bies. Advancing the technolo- gy further required starting a company. In 2005, Wodicka, Mansfield and Juan founded SonarMed together with Greg Ayers, who had earned both his bachelor's and doctoral de- grees in engineering from Pur- due and saw the device's poten- tial for commercialization. The Purdue Research Foundation Office of Technology Commer- cialization licensed the acous- tic guidance technology, which by then had two U.S. patents, to SonarMed for commercial development. Ayers was So- narMed's first CEO. The researchers wouldn't get FDA clearance for testing the technology in adults until 2010. But SonarMed was on the brink of bankruptcy. An unlikely success in bring- ing new technology to the NICU In 2012, Tom Bumgardner became the CEO of SonarMed in the midst of the startup's fi- nancial troubles and lack of suc- cess breaking into the NICU market. He and his business partner, David Gunn, worked to save SonarMed from collapse. "David and I were naïve enough, not knowing much about medical devices. If we had known about medical de- vices, there was no way we would have taken this project on," Bumgardner said. Bumgardner and Gunn had talked the rest of SonarMed leadership into working for free for several months while they focused on getting the financial capital the startup needed. "We would raise more money and try to make progress, have to cut salaries. … It was a hard road. We got down to where we had just $5,000 in the bank a couple times along the way. I had a daughter in college and didn't know how we were going to pay for anything," Bumgard- ner said. Under Bumgardner's lead- ership, the technology final- ly got tested in adults at the University of Texas MD An- derson Cancer Center. The de- vice then had to undergo a se- ries of upgrades to resolve re- maining issues, such as invent- ing a mucus-proof sensor that could monitor the endotrache- al tube without needing to be cleaned or replaced. Sven Sch- reiber, who got his bachelor's degree from Purdue in mechan- ical engineering, led work as SonarMed's director of opera- tions redesigning the device to make it more manufacturable and aesthetic. But despite the device's promises and success in adult clinical trials, there remained the challenge of convincing hospitals to use it – even though not even the ICU had technolo- gy that could continuously mon- itor obstruction and positioning of breathing tubes. The much more dire effects of unplanned extubations in ba- bies compared with adults ulti- mately convinced hospitals to give the SonarMed airway mon- itor a try. "We had started going to ICUs to show them the So- narMed airway monitor and they would say, 'Well you know, we kind of have a problem, we kind of don't,' and everybody understood it. But then we started talking about the NICU, and everybody got it and want- ed it," Bumgardner said. The SonarMed airway mon- itor's quick impact at Hunting- ton and other hospitals attract- ed the attention of Medtronic, which officially partnered with the startup in 2016. In 2018, Medtronic began investing in SonarMed, believing that the tool would bring more value to NICUs. Drains added to fix problem on Highway 61 Two drains were added to fix a drainage problem on Highway 61 at the south edge of Petersburg. Water has been pooling there after it rains for more than 40 years. Grant Brittain, of Otwell, operates a loader for Ragle, digging up broken up concrete to make way for a new drain on the east side of Highway 61. Farmers Market opens The Farmers Market on Eighth St., in Petersburg, opened Saturday morning for the first time this year. It will be open every Saturday beginning at 9 a.m. Above: Val- erie Searls sells vegetables to Dian Martin, of Winslow, as her husband, Kelly, waits patiently.