Researchers have developed a 3D-printed splint that has been used to save the life of a 20-month-old infant.
Kaiba Gionfriddo was 6 weeks old when he was diagnosed with severe tracheobronchomalacia (TBM), a birth defect that causes the windpipe to collapse, blocking air flow into the body.
The condition, affecting one in every 2,100 babies, meant that Kaiba's heart would frequently stop beating, and although he had the aid of a medical ventilator, he had to be resuscitated daily by doctors.
Researchers from the University of Illinois, the Institute of Genomic Biology (IGB), and the University of Michigan developed a 3D-printed splint, which was sewn around Kaiba's tracheotomy tube in order to expand his collapsed windpipe and provide support for tissue growth.
Tracheobronchomalacia is an uncommon condition that occurs when the airway walls become weak, causing the airway to collapse during breathing or coughing. It is the most common congenital central airway condition, but can frequently be misdiagnosed as asthma.
How the splint was created
Matthew Wheeler, Professor of Animal Sciences at the University of Illinois, holding a 3D-printed, bioresorbable airway splint.
The research team previously tested 3D-printed, bioresorbable (degradable) airway splints in 2-month-old pigs who had the same condition and similar biomechanical and anatomical properties as a growing human trachea.
A CT scan of a pig's trachea was sent to Professor Glenn Green at the University of Michigan, who, with colleague Scott Hollister, used the scan alongside a 3D computer-aided design program in order to design and print the splints, which were made from an FDA-approved (Food and Drug Administration) material called polycaprolactone (PCL).
A procedure was carried out to implement the splint device in a pig suffering from the defect. After the splint was sewn into the pig's windpipe, its tracheobronchomalacia was gone.
Matthew Wheeler, Professor of Animal Sciences at the University of Illinois, says:
"Essentially, all our breakthroughs in human clinical medicine have been initially tested or perfected in animal models. Through the use of animal models, scientists and doctors are able to perfect techniques, drugs and materials without risking human lives."
Inserting the splint into baby Kaiba
Kaiba's parents, April and Brian Gionfriddo believed their baby's chance of survival was small. But a doctor at Akron Children's hospital in Ohio informed them that researchers at the University of Michigan were testing the new airway splints.
Emergency clearance was given by the FDA, and Kaiba's splint was made using computer-guided lasers in order to print, stack and fuse thin layers of plastic.
The operation was carried out on February 9th, 2012, at C.S. Mott Children's Hospital, where the splint was sewn in to Kaiba's airway. There is a slit in the side of the splint, which allows for growth alongside the airway.
Since the operation, Kaiba's trachea has fully reconstructed itself. Researchers say his body will reabsorb the splint as the PCL degrades, and his tracheotomy tube will be removed in a year without causing any harm.
Prof. Green said in a report featured in the New England Journal of Medicine:
"It was amazing. As soon as we put the splint in, the lungs started going up and down for the first time and we knew he was going to be ok."
Wheeler says: "All of our work is physician inspired. Babies suffering from tracheobronchomalacia were brought to ear, nose and throat surgeons, but they didn't have any treatment options. They turned to us to engineer a cure."
The future of 3D-printed splints in treating tracheobronchomalacia
Wheeler says that he would like to progress this method even further by adding stem cells to the splint to speed up the healing process.
But he adds that further trials of this procedure will be required in order to show the long-term success before it can be used to save other children suffering from tracheobronchomalacia.
Wheeler says: "We have a reputation for being excellent in this area. We would like to capitalize on the expertise and the facilities that we have here in order to continue to conduct life-saving research. I am hoping that this story will encourage more people to come to us and say 'Hey, we'd like to develop this model.'"
In the video below, the parents of Kaiba Gionfriddo tell their story and Scott Hollister and Glenn Green discuss the procedure undertaken.