Yale Graduates Hope Device Will Encourage Brace Compliance in Children with AIS

The Smart Strap Monitoring System Provides Real-Time Feedback When Yale University, New Haven, Connecticut, graduates Levi DeLuke, Sebastian Monzon, and Ellen Su were accepted into the university's Center for Engineering Innovation and Design's (CEID's) 2013 summer fellowship program, it was DeLuke who suggested that the team tackle adolescent idiopathic scoliosis (AIS) as it seemed to lag in treatment innovation. The team took a procedural approach toward problem solving. That meant the students had to pore through volumes of research materials, visit support groups, research existing patents, interview and shadow physicians and orthotists, as well as interview patients, their parents, and other family members. Through that work, they identified two salient problems with scoliosis treatment: compliance with the wear schedule and ensuring that the brace is worn tight enough to be effective. Prescribed wear times can be up to 23 hours per day-a challenge for even the most disciplined user-and if not worn correctly, the effort may be wasted. [caption id="" align="alignright" width="350"] From left: Su, DeLuke, and Monzon. Photographs courtesy of 109 Design.[/caption] "We recognized the importance of proper brace wear for the treatment of scoliosis and understood some of the limitations of the current technologies," says DeLuke, who was diagnosed with AIS at the age of ten. He wore a brace for three years before undergoing surgery to correct the curve in his spine. "Wearing a brace as a kid is tough. It's hard for them to understand the importance...," he says. "[Braces are] uncomfortable and often noticeable in school." DeLuke says he considers himself fortunate because his surgery went well and he hasn't had major complications since having the operation nearly a decade ago. "I have to be smart about it," he says. "I don't go out and play tackle football." Smart Straps With the two issues identified, the team went to work and developed a compliance and feedback monitoring system that can be attached to a scoliosis brace. At the end of that summer fellowship, they had a working prototype. The overall goal of the system, and scoliosis bracing in general, is to reduce the likelihood of surgery, DeLuke says. "We aim to do so by providing data to patients, parents, and doctors that can enable the incentivization and optimization of proper brace wear," he says. The system consists of two parts: a medical device and a software platform. "Smart straps" that replace the existing Velcro straps of a scoliosis brace with an integrated electronic module make up the device component, says DeLuke, who graduated with a mechanical engineering degree. It can detect how long and how tightly the brace is being worn and has been designed to provide immediate feedback to patients via vibration, light, or sound. Through the software component and a smartphone application, the data is sent wirelessly to the patient and his or her parents, providing real-time compliance information. "The value in our system lies in the actionable data it can provide to help parents and doctors make more informed decisions about treatment," Monzon says. "And also in facilitating incentive systems in the smartphone and web applications that promote rewards for better brace wear." Real-time Data The three main methods of treating AIS, which is often detected during school screenings or sports physicals, are observation, bracing, and surgery. Patients are typically under observation until their curves reach an angle of 20 degrees, according to Su, who graduated with a design degree. Once the curve progresses past that point, patients are fitted with a brace to prevent the curve from increasing as they grow through puberty. If the curve reaches 50 degrees, either because it was caught too late or the bracing was ineffective, the patient has to undergo spinal fusion surgery. Says DeLuke, "These are very invasive surgeries," with a long recovery time, and can often leave the patient unable to twist or bend his or her back. Until recently, patients and their parents would self-report how long the child wore the brace each day, DeLuke says. While this is still common, he says, progress has been made on temperature-based monitors that allow physicians retroactively to track how long the brace is being worn each day, Su says. These devices are embedded in the custom-made braces during fabrication. Data is downloaded roughly every three months during a visit to the physician or orthotist, she says, which makes the information unavailable between visits. Also, while these monitors do provide more reliable wear data, they are unable to provide data regarding fit of the braces. However, existing braces can be retrofitted with the team's smart straps to collect data about the correct wear time as well as daily wear quality. "The entire procedure to remove the old straps and fit the new straps takes less than ten minutes and can be done in the doctor's office," Su says. "We are able to monitor how long and how tightly the brace is being worn, a factor that has been shown to positively affect treatment." The team's smartphone app will let parents and children track brace wear every day, allowing them to have better goalsetting and incentive systems in place to encourage the patient to wear the brace, DeLuke says. In the future, parents will be able to set their own rewards to encourage their children to wear the braces as prescribed. "We hope children become engaged with our system and keep track of progress over time, in a method similar to the recent trends in fitness tracking and monitoring," he says. The straps are also able to give patients immediate feedback when they tighten the brace, letting them know that the brace has been tightened to the correct level. This allows patients to tighten the brace by themselves, something that has not been possible with braces that have straps in the rear, DeLuke says. "We can provide vibration or sound feedback to notify the patient when the brace is tightened correctly," he says. "A small feature like this can reduce the need for help donning a brace, something that seems important for kids who want to be independent." Making Modifications One area for improvement is developing a smaller battery with a longer life. The device, about the size of a deck of playing cards, has a battery life of about two weeks. "There have been a few versions," DeLuke says. "The current one is smaller and is the first being worn by patients." It's currently being tested in a pilot study at the Yale-New Haven Hospital to determine the ideal frequency of data collection and how long it needs to be active. "Optimizing these intervals will be able to greatly extend our battery life," Su says. "We are also testing our software interfaces and working closely with parents, children, and doctors to make sure that the interfaces provide the necessary information and features for each group." The team will also start working with a professional engineer to shrink the size of the device and reduce the profile, which will make it more appealing to patients and parents, Su says. 109 Design As a result of the 2013 summer fellowship, DeLuke, Monzon, and Su formed a company, which they named 109 Design because it was in CEID room M109 that they planned, problem solved, and developed the prototype. The CEID room provided a space to exchange ideas and advice that ultimately improved everyone's projects, according to Monzon, a political science major and company cofounder, along with DeLuke and Su. "We naturally developed an affinity for [M109]," Monzon says. Also, says DeLuke, "We wanted to have a name that left open possibilities to work on areas other than scoliosis treatment in the future." With a working prototype in hand, the three wanted to go a step further. "We wanted to explore the potential of commercializing our invention," says Monzon, who met DeLuke as a freshman when they were roommates. DeLuke and Su met on campus when they helped cofound the Yale chapter of Design for America. A Bright Future When the new year began, 109 Design saw a future in its scoliosis brace-wear tracker and the kind of feedback it could provide to children, their parents, and their physicians, Monzon says. The team applied to and was accepted into the 2014 Yale Entrepreneurial Institute (YEI) Summer Fellowship. YEI's Demo Day in July was the final event of the summer, where the fellowship teams had the opportunity to share their startups with a large community of those interested in entrepreneurship. 109 Design won the audience favorite award, a small cash prize, and was introduced to a new mentor, who has since become extremely helpful to the startup. Betta Ferrendelli is a freelance writer based in Denver, Colorado.

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