Device to Stop Postpartum Hemorrhaging Set to be Tested in Clinical Trials

Italian researchers at the Politecnico di Milano (Polytechnic University of Milan) have developed a potentially life-saving device for new mothers in high-risk settings. A result of the BAMBI (Balloon Against Maternal BleedIng) project, the low-cost medical device to stop postpartum hemorrhages is ready for the final phase of testing—clinical trials.

The project’s idea was put forward by Alberto Zanini, a gynecologist and former head of the Obstetrics and Gynecology Unit at the Sacra Famiglia Hospital in Erba, Italy. He contacted the university to develop his intuition, assisted by a multidisciplinary team of professors and researchers from the Giulio Natta Department of Chemistry, Materials and Chemical Engineering, the Department of Mechanics, and the Design Department (which was involved in the initial phase only).

The multidisciplinary approach we took when designing the device made it possible to identify and experimentally test all the requirements needed to develop an effective and affordable solution,” stated Serena Graziosi, a mechanical engineering professor.

BAMBI is a simple, quick, affordable engineering solution. The BAMBI prototype consists of a kit with components that are available in low-resource contexts, integrated with a patented connector that guarantees the system’s safety and assembly, making it easy to use and mechanically efficient, according to the university. The kit includes a rectal probe, probe cover, and bag of saline solution fitted with a clamp. In the event of a uterine hemorrhage following a fetal delivery, the probe is inserted and positioned in the uterus. The probe cover, which is attached to the probe through the connector, is inflated with saline solution, turning it into a balloon that stops blood loss directly from the inside.

BAMBI is now ready to shift from the laboratory to production through a call for patent development programs using funding for proof of concept projects as part of MUSA – Spoke 3 “Deep Tech: Entrepreneurship & Technology Transfer’ “based on resources from the NRRP.

“With BAMBI, we want to show that it is possible to combine technological innovation with a social impact. Our goal is to offer a concrete, affordable and safe solution to stop postpartum hemorrhaging,” said Maria Laura Costantino, scientific coordinator of the BAMBI project and a professor in the Department of Chemistry, Materials and Chemical Engineering. “We aim to make this device available wherever it is needed, even in the most vulnerable situations by using an essential, accessibility-oriented engineering approach and a ‘social’ patent. In fact, all the researchers involved decided to waive any rights to the patent, in order for it to have the most possible widespread availability.”