SimpleSilo offers affordable lifesaving solution for gastroschisis in low-resource settings

In low-resource settings, babies born with gastroschisis - a congenital condition in which the developing intestines extend outside the body through a hole in the abdominal wall -face life-threatening challenges. While survival rates in high-income countries now exceed 90% thanks to advanced medical tools and neonatal care, infants in resource-constrained medical settings still face high mortality rates, partially because of a lack of access to the lifesaving equipment needed to treat the condition.

A team of engineers and pediatric surgeons led by Rice University's Rice360 Institute for Global Health Technologies is working to change that. Their innovation? A simple, low-cost and locally manufacturable medical device, known as the "SimpleSilo," designed to provide lifesaving treatment for gastroschisis at a fraction of the current cost and made from locally available materials.

"We focused on keeping the design as simple and functional as possible, while still being affordable," said Vanshika Jhonsa, a recent Rice alumna and first author of the study recently published in the Journal of Pediatric Surgery. Jhonsa, who is now a medical student at UTHealth Houston, also won the 2023 American Pediatric Surgical Association Innovation Award for the project. "Our hope is that health care providers around the world can adapt the SimpleSilo to their local supplies and specific needs."

In standard treatment, preformed silo bags are used to protect the exposed intestines and gently return them into the abdominal cavity gradually. These devices are effective but expensive: A single-use bag can cost between $200 and $300, a price well beyond the reach of many hospitals around the world. Alternatives exist, but they typically require surgical sewing, which creates holes in a baby's abdomen and the bag material that can increase the risk of infection. Additionally, these alternatives lack the structural integrity needed to safely support the intestines.

The SimpleSilo changes that. Constructed from a saline bag, oxygen tubing and a commercially available heat sealer, the device mimics the function of commercial spring-loaded silo bags without the high cost.

Our goal was to replicate the functionality of commercial silo bags using inexpensive, easy-to-source materials. The result is a bag that costs less than $2.05 to make and can be assembled by hospital staff in under an hour. Working with surgeons in sub-Saharan Africa where expensive commercial silo bags are unavailable, I'm excited to offer this solution as I know that it will be saving lives of babies born with gastroschisis."

Bindi Naik-Mathuria, pediatric surgeon at UTMB Health and corresponding author of the study

To evaluate the SimpleSilo, the team subjected it to a rigorous series of laboratory tests. The device demonstrated a fluid leakage rate of just 0.02 milliliters per hour, which is comparable to commercial silo bags, and it withstood repeated disinfection without compromising its performance.

"The students' big innovation was to focus on materials already available in low-resource hospitals and to use accessible manufacturing methods - in this case, cutting materials with scissors and using a food-grade heat sealer to reassemble them," said Meaghan Bond, lecturer and senior design engineer at Rice360. "The early laboratory testing reported in the paper suggests these easy-to-make bags will stand up to disinfection methods and actual use."

In a simulated in vitro test using cow intestines and a mock abdominal wall, the SimpleSilo achieved a 50% reduction of the intestines into the simulated cavity over three days, again matching the performance of its high-cost counterparts.

What sets the SimpleSilo apart is its ease of production and usability in real-world hospital settings. Pediatric surgeons in Kenya successfully assembled and used the bag in clinical care, reporting positive outcomes and expressing confidence in continuing its use.

"Gastroschisis has one of the biggest survival gaps from high-resource settings to low-resource settings, but it doesn't have to be this way," Bond said. "We believe the SimpleSilo can help close the survival gap by making treatment accessible and affordable, even in resource-limited settings."

Plans are underway for a formal clinical trial in East Africa. Should the results continue to be positive, the team hopes to make open-source instructions widely available, enabling more hospitals to produce their own SimpleSilo devices.

"This project is proof that thoughtful engineering and global collaboration can save lives," Bond said, noting that it was led by undergraduate students in a global health technologies class. "We don't have many class projects make it to a peer-reviewed publication, and I'm so proud of the extra work these students put in to get there. Sometimes, the most powerful solutions are the simplest ones."

Additional authors on the study include Shreya Jindal and Shriya Shah, both undergraduates at the time of the study, and Mary Seifu Tirfie, a current Rice360 Global Health Fellow.

The work was funded by Rice, Rice360 and its generous donors.