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A new device for fetal therapy

June 30, 2023
A group of students stands together for a photo in front of a flowering bush.

Every year, 120,000 babies are born in the United States with birth defects, according to the Centers for Disease Control and Prevention. The good news is that emergency in-utero surgery can repair severe congenital disorders before a baby is born.

But such surgery—a minimally invasive, ultrasound-guided procedure involving accessing the uterus via a port inserted through the mother’s abdomen—carries risks, including that of membrane rupture, which occurs in 30% to 40% of all patients.

The high rate of such surgical complications motivated biomedical engineering third-year student Selena Shirkin to tackle this real-world health care challenge. She already had some experience in the medical technologies industry: Her earlier work on Stetpulse, a tool to sterilize stethoscopes during clinical practice, received funding from VentureWell, a higher education network. So in the spring of her sophomore year, she began leading a team to design a better solution for fetal therapy.

Shirkin and her team quickly zeroed in on preventing membrane rupture. “This is when the amniotic fluid leaks out into the space between the uterine wall and the amniotic membrane,” she says. “That causes the membrane to strip off, like wallpaper peeling off a wall. And that causes the mother’s water to break, leading to preterm labor.” Since most surgical interventions take place before 25 weeks of gestation, membrane rupture can have serious consequences, including the death of the prematurely born baby.

During their research phase, Shirkin and her team learned that the main cause of membrane rupture is the use of devices not specifically intended for fetal surgical therapy—oversized
and often dull instruments that were designed for cardiovascular, laparoscopic, and other endoscopic surgeries.

“Our goal is to create a new access port system specifically for the uterine environment,” says Shirkin. “It would be inserted into the mother’s womb and function as a tunnel into the uterus.”

Working in collaboration with Ahmet Baschat, director of the Center for Fetal Therapy and his team of maternal-fetal medicine specialists at the Johns Hopkins University School of Medicine, the student team developed a novel port system with two parts: a sharper introducer needle, also known as an obturator, that would pierce through layers of tissue, including the uterine wall, without causing membrane rupture; and a port sheath that would radially expand, allowing surgeons to insert varying sizes of instruments into the uterus. The device is currently in the prototype stage.

“My goal is to push this project as far beyond the classroom as I can,” says Shirkin. “I think we can really make a difference.”

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