Every year, thousands of children in the U.S. are born without arms, limiting their development and affecting their quality of life. But now, there is hope that they can receive affordable and customizable prosthetics, capable of boosting their growth and potential.
Their savior is a team of researchers from Limbitless Solutions, a non-profit group at the University of Central Florida, and Oregon Health and Science University (OHSU), who have teamed up to launch the first U.S. clinical trial of bionic arms for children produced on 3D printers.
The two leading researchers are Albert Manero, CEO and co-founder of Limbitless Solutions, and Albert Chi, an associate professor of surgery in the OHSU School of Medicine.
Being born without limbs has traditionally created many developmental complications and health concerns with very few treatment options.
The therapy and material that goes into effective prosthetics for children can exceed $100,000, and children quickly outgrow the devices.
But the costs and complications can be alleviated through the researchers’ revolutionary 3D printing technique.
“Using 3D printing we are able to reduce manufacturing costs and prototyping duration for small batches of parts,” said Manero.
“Our in-house design electronics hardware and software also helps us to keep our hardware costs down.”
The researchers can produce their new prosthetic devices in the labs at UCF for less than $1,000 dollars in hardware costs.
“Where this goes from here is going to be huge,” Chi said in a statement.
“It’s my personal aspiration to provide advanced prosthetics to all those in need. Making it affordable and accessible is the goal, and I really do believe 3D printing technology is the solution.”
Through 3D printing, children born without arms will be able to customize their bionic limbs to match their personality.
“It allows kids to be kids and understand their opportunities are limitless,” Manero said in a statement.
How the bionic limbs work
Limbitless creates myoelectric arms with a pair of lead wires, placed on the skin, that are triggered to activate when children flex their muscles.
The latest model of the affordable bionic arm uses multiple motors and smartphone technology to increase a child’s ability to make gestures and grip various objects.
The clinical trial
For the year-long clinical trial, the researchers will recruit 20 children to be fitted with their custom-designed bionic arms.
The children will range from ages 6 to 17 and will come primarily from the Southeast and Pacific Northwest.
The children will be taught how to operate the limbs and will receive occupational therapy at centers in Portland and Orlando.
Throughout the trial, the researchers will gauge the children’s quality of life and ability to use the limbs for specialized tasks.
“The clinical trials bring our new bionic arm into the medical environment and will provide children participating with the occupational therapy support,” said Manero.
The trial will enable the researchers to collect data on how the children are using the limbs and how their learning progresses, explained Manero.
Additionally, the clinical trial will help determine if the bionic arm could pass the U.S. Food and Drug Administration’s (FDA) test for market clearance. This is essential because, if it passes, the device could be covered by insurance.
The team expects to apply for FDA clearance, but the researchers recognize that it could take a few years, said Manero.
Currently, the team is focused on studying the bionic arm through clinical trials so that the researchers can continue to make adjustments based on the feedback, he explained.
Limbitless collaborators, including UCF College of Medicine Professor Juan Cendán, hope that this is just one of many trials that will emerge across the country to establish a non-profit model for the 3D printing of custom-designed prosthetics for children.
History of Limbitless
The Limbitless bionic-arm project first began in 2014, when Manero was still a graduate student. Manero and a group of friends were sitting around a kitchen table when a mother asked him to create a bionic arm for her son, and the team began building prosthetics that summer.
Since the establishment of the non-profit organization four years ago, the group has tied together elements of design, art, engineering and video game development to train children to use the devices.
In 2016, Limbitless teamed up with UCF professors to develop a video game to help train children’s muscles before they receive bionic arms.
Powerful partnership
UCF has always found pride in its ability to utilize partnerships.
“As America’s Leading Partnership University, we engage others of common cause to achieve what no one entity can accomplish alone,” UCF President John C. Hitt said in a statement. “Limbitless has taken these lessons to heart and is changing the lives of many.”
Through partnering with OHSU, Limbitless has gained a vastly experienced surgeon and biomedical engineer.
“Dr. Chi brings a rare combination of expertise as a surgeon and as a biomedical engineer, and OHSU is proud of his innovative work to improve the lives of patients affected by limb loss,” OHSU President Joe Robertson said in a statement.
Since 2016, Chi has directed the Targeted Muscle Reinnervation program at OHSU. Chi has developed a method to surgically reassign nerve endings so that patients can move their prosthetics by thinking.
The trial is officially open to children all over the country, but being able to commute to Orlando or Portland is critical to the year-long process.
Families interested in applying for the clinical trial can sign up on the Limbitless Solutions website.
