May 1 2015
Researchers from University of Michigan have successfully helped in finding a solution to treat severe tracheobronchomalacia using customized 3D printed airway splints.
Dr. Scott Hollister and Dr. Glenn Green
Three babies at the University of Michigan’s C.S. Mott Children’s Hospital suffered a life-threatening condition called tracheobronchomalacia, which causes their windpipe to occasionally collapse, thereby hindering normal breathing. This condition had no possible no cure and chances of survival were slim.
The revolutionary 3D printed airway splints were placed inside the babies to assist in keeping their airways open, restoring their breathing and saving their lives, thereby becoming the first few cases in the world to gain from this research work.
The UM researchers kept close watch over the three cases to see how they coped with the implanted bioresorable splints. Their findings have been published in the current issue of Science Translational Medicine.
“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,” says senior author Glenn Green, M.D., associate professor of pediatric otolaryngology at C.S. Mott Children’s Hospital.
“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. We found that this treatment continues to prove to be a promising option for children facing this life-threatening condition that has no cure.”
Early treatment of tracheobronchomalacia can avoid many complications related to traditional treatment such as mechanical ventilation, tracheostomy, long periods of hospitalization, improper absorption of food, respiratory and cardiac arrest, and distress. So far, no complications have been reported in the three cases after implantation of splints.
The research findings reveal that these three cases could be taken off ventilators and did not require narcotics, paralytics and sedation. They also noticed changes for the better in multiple organ systems. Additionally, the babies were relieved of immunodeficiency-causing proteins, which made absorption of food difficult. Thus they did not need intravenous therapy anymore.
Green and his colleague Scott Hollister, Ph.D., professor of biomedical engineering and mechanical engineering and associate professor of surgery at UM, used 3D printing to create and implant the custom-made tracheal splints for each patient. They built the splints using CT scans of the patients’ tracheas, combining it with image-based computer models using laser-based 3D printing.
Each baby had the splint sewn around their airways to expand the trachea and bronchus and provide it a skeleton to assist in correct growth. Over time the splint will be reabsorbed by the patient’s body. CT and MRI scans were performed after the growth of the airways. The scans showed how the splint allowed airway growth. The FDA gave emergency clearance to the doctors to perform these procedures.
“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.”
There have been questions regarding the safety and rare potential complications of these splints. However, Richard G. Ohye, M.D., head of pediatric cardiovascular surgery at C.S. Mott who handled the surgeries, states that the cases offer the foundation to investigate a clinical trial in the future that could assist more children with less-severe types of tracheobronchomalacia.
The splints have begun dissolving as expected, and the doctors believe that soon these babies will have normal tracheas without any traces of the potentially fatal tracheobronchomalacia.