Apr. 30, 2015 | By Alec

3D printing technology has really been making a name for itself in the medical world recently, but it’s been around for a lot longer than you might think. The first 3D printed medical applications were developed a few years ago, but due to the lack of all those success stories we enjoy today, doctors were far more cautious and careful. But when it’s a matter of life and death, you just have no choice.

That seems to be the core of the story of three babies whose lives were saved by 3D printed ‘trachea splints’ in the University of Michigan's C.S. Mott Children’s Hospital. As has become apparent from three cases reported in the latest issue of Science Translational Medicine, doctors and researchers from that hospital did groundbreaking work in a time when doctors didn’t quickly resort to 3D printing technology. A 3D printer was used to create a medical device being called a 4D airway, which saved the lives of three baby boys with life-threatening breathing problems. This amazing new medical implant is designed to change shape as the child grows and help them keep breathing.

As Glenn Green, M.D. and associate professor of pediatric otolaryngology at Mott Children’s Hospital revealed, they were doing something truly revolutionary. ‘These cases broke new ground for us because we were able to use 3D printing to design a device that successfully restored patients' breathing through a procedure that had never been done before.’ This is also the first 3D-printed implant specifically designed to change shape over time.

All three cases were tragic and usually fatal. All three babies, Kaiba, Garrett and Ian, suffered from the same life-threatening condition: a terminal and incurable form of tracheobronchomalacia, which causes the windpipe to periodically collapse and make breathing impossible. Kaiba was rushed to hospital when he turned blue, while Garrett spent the first year of his life in hospital attached to a ventilator. Perhaps worst of all, baby Ian's heart stopped beating after just a few months on this earth.

‘Before this procedure, babies with severe tracheobronchomalacia had little chance of surviving. Today, our first patient Kaiba is an active, healthy 3-year-old in preschool with a bright future. The device worked better than we could have ever imagined. We have been able to successfully replicate this procedure and have been watching patients closely to see whether the device is doing what it was intended to do,’ the professor said in a press release. ‘We found that this treatment continues to prove to be a promising option for children facing this life-threatening condition that has no cure.’

Kaiba after surgery.

In all three cases, groundbreaking 3D printed devices that hold airways open were implanted, which restored breathing in all babies and saved their lives. While big news at the time, it’s great to see that these kids are still doing well today, three years since the first baby (Kaiba) underwent surgery. There weren’t even any complications. In fact, all findings suggest that an early treatment of tracheobronchomalacia through 3D printed splints can prevent the occurance of all the typical complications associated with trachea surgery, such as tracheostomy, prolonged hospitalization, mechanical ventilation, cardiac and respiratory arrest and food malabsorption. None of the patients needed further breathing support, paralytics, narcotics or sedation. The study also found improvements in the functioning of multiple organ systems.

That’s all great to hear, but this procedure was a bit more terrifying in 2012. Professor Green enlisted the help of his colleague Scott Hollister, professor of biomedical engineering and mechanical engineering and associate professor of surgery at U-M. Using CT scans and 3D printing technology, they developed a customtrachea splint for the then three-month-old Kaiba Gionfriddo. Reportedly, laser-based 3D printing technology was used. That splint was sewn around the boy’s airways to expand the trachea and bronchus and essentially function as a supporting skeleton that aids growth. The splint was also designed to be absorbed once it was no longer needed, though the situation of the boy’s airways was closely monitored through CT and MRI scans. During the entire prodecure, doctors had emergency clearance from the FDA.

As the doctors saw no abnormalities in Kaiba’s situation (in fact, they saw the opposite), the procedure was repeated with Garrett Peterson and Ian Orbich. In all three cases over the last three years, the device was shown to open up to allow airway growth. ‘We were pleased to find that all of our cases so far have proven to improve these patients' lives,’ Green says. ‘The potential of 3D-printed medical devices to improve outcomes for patients is clear, but we need more data to implement this procedure in medical practice.’

Authors have further argued that other potential complications of these 3D printed implants are not yet evident, though it has already been enthusiastically received by specialists in the field. Richard G. Ohye, M.D., head of pediatric cardiovascular surgery at C.S. Mott who performed the surgeries, says the cases provide the groundwork to potentially explore a clinical trial that could help other children with less-severe forms of tracheobronchomalacia in the future.

Most importantly, the three babies are now doing fine. Three-year-old Kaiba’s splint is already dissolving and doctors expect that his trachea will exhibit no signs of the nearly fatal complication. ‘The first time he was hospitalized, doctors told us he may not make it out,’ Kaiba's mother April Gionfriddo told reporters. ‘It was scary knowing he was the first child to ever have this procedure, but it was our only choice and it saved his life.’

The story of the now two-and-a-half-year-old Garett and the 17-month-old Ian is the very similar. ‘We were honestly terrified, just hoping that we were making the right decision,’ Ian’s mother Meghan Orbich remembers. ‘I am thankful every single day that this splint was developed. It has meant our son's life. I am certain that if we hadn't had the opportunity to bring Ian to Mott, he would not be here with us today.’

The researchers are now studying the safety of the devices and pursuing a larger clinical trial for the 4D biomaterials.



Posted in 3D Printing Applications


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