Advancing a New Fetal Shunt for Aqueductal Stenosis
Recently, I had the privilege of interviewing Dr. Stephen Emery, MD, and Dr. Youngjae Chun, PhD. Dr. Emery is a Professor of Obstetrics, Gynecology, and Reproductive Sciences. He is also the Director of the Center for Innovative Fetal Intervention at Magee-Women’s Hospital, part of the University of Pittsburgh Medical Center. Dr. Chun is a professor in the Department of Industrial Engineering at the Swanson School of Engineering and the head of the Translational Medical Device Research Laboratory, a collaborative space shared between the Industrial and Bioengineering Departments. With help from the CMI, Dr. Emery and Dr. Chun combined their expertise to develop a fetal shunt for aqueductal stenosis.
Aqueductal stenosis is a cause of hydrocephalus in which cerebrospinal fluid (CSF) builds up in the brain due to blockage of a tube that connects the third and fourth ventricles of the brain. This causes CSF to accumulate, press on the brain, and destroy tissue. Currently, there is no treatment available for the unborn fetus. In the 1980s, improvements in ultrasound resolution and clinical adoption made it possible for doctors to look through the mother’s abdomen to view the fetal brain. This technology allowed a hydrocephalus diagnosis to be made and subsequently a shunt to be placed. However, in 1982, an international registry reviewed the results and discovered that these shunts were causing more harm than good. In 2014, Dr. Emery reviewed these results and discovered the issue was not the shunts. Rather, due to the technology available, doctors at that time could not differentiate aqueductal stenosis from other forms of hydrocephalus, which do not benefit from shunting.
Dr. Emery believed that with modern technology, an accurate diagnosis could finally be made and that shunting would work. Through the CMI network, Dr. Emery was introduced to Dr. Chun, who enthusiastically agreed to provide engineering expertise for the project. After two CMI grants, Dr. Emery and Dr. Chun collaborated with undergraduate students and a PhD student to fabricate prototypes and establish animal models aimed at normalization of intracranial pressure. Being part of this work gave the students hands-on experience with medical device design, prototyping, and testing, which helped prepare them for future careers in the field. They also conducted in vitro and in vivo testing on the prototypes. The device they call the Pitt shunt will be thin and small, have an anchoring system, and will be placed in the fetal skull using ultrasound guidance through the mother’s abdominal wall. This ensures no anesthesia, x-ray exposure, or surgical risk for the mother because the shunt is placed under local anesthetic and IV sedation.
The initial support from the CMI built the foundation Dr. Emery and Dr. Chun needed to receive a $2.3 million incubator grant from the National Institute of Health Blueprint MedTech program. In addition to this funding, the program is now connecting the team with bioengineers and others who have experience getting neurological devices through the FDA. This will shape the next stage of their development through commercialization.
At the end of our discussion, Dr. Emery and Dr. Chun took the time to thank CMI for connecting the team, supporting the early stages of the project, and believing in their vision.
-Jana Citrenbaum