Indian-origin researcher makes splitters for ventilator

iSAVE re-purposes flow valves to support two patients

May 17, 2021 11:44 pm | Updated 11:44 pm IST - CHENNAI

The first batch has been delivered to two hospitals in Kerala.

The first batch has been delivered to two hospitals in Kerala.

A team of researchers in the United States has come up with splitters for ventilators that will address the shortage of the life-saving equipment. The Central Drugs Standard Control Organisation, Bengaluru, recently approved the equipment. IndVentr is the Indian partner making the device.

The team validated the device in India, and the first batch has been delivered to two hospitals in Kerala. By the month-end, 100 more units will be deployed at several hospitals.

Called iSAVE (Individualized System for Augmenting Ventilator Efficacy), the equipment re-purposes the flow valves of a ventilator to provide customised support to two patients.

Ventilator support to groups of patients in emergencies has been tried out with limited success, as there are concerns about contamination and the right parameters of the patients being ensured. Excess or too little flow of oxygen could harm the lungs. The team took up the challenge when COVID-19 surged through the U.S., and hospitals struggled with a huge inflow of patients. By the time the team validated its device, the flow of patients had fallen.

Earlier this year, Shriya S. Srinivasan and her team were in discussion with Indian health officials. But the interest in their equipment was low.

The team then began talking to smaller countries, such as Ecuador, Lebanon, Brazil and Italy.

Dr. Srinivasan, a biomedical engineer, is the daughter of immigrant parents. She visits India frequently to give bharatanatyam performances. She did her Ph.D in medical engineering and medical physics at the Massachusetts Institute of Technology and Harvard Medical School. She took up Project Prana on the sidelines of her ongoing post-doctoral work.

“The right amount of pressure and tidal volume make sure that the lungs receive the correct requirement of oxygen. With the digital respiratory monitor, it is easy to monitor both patients,” Dr. Srinivasan says. “The goal is to alleviate the human resource limitation, while making nursing and monitoring safe for both the nurse and the patients.”

Easy to assemble

The equipment can be assembled with an existing ventilator in less than 10 minutes even by an inexperienced staff member. “It has been rigorously tested, and the research and the findings have been published in the medial journal, Science Translational Medicine ,” she explains.

The device has been validated on pig models. The researchers used a large and small animal each and compared the values for individual ventilation and combined ventilation, which showed no significant changes, she says. “The device is such that a small person and a large person can be ventilated at the same time, providing versatility to the equipment. Training manuals and videos to help have been prepared.”

As the pandemic surged in India, IndVentr received funds to make the equipment.

“Our mission is equitable access to care. Last year, Seattle, Boston and New York hospitals were running out of ventilators. We jumped in; as biomedical engineers, we had the tools and it was our duty. My team brought in anaesthesiologists, pulmonologists, respiratory therapists and engineers who could design holistically and with patient safety in mind,” she says.

The team got help from Philips Healthcare and submitted iSAVE to the U.S. Food and Drug Administration for emergency use authorisation. It ran the Michigan Test Lung System on the device.

Prakash Bare, head of IndVentr Consortium, says that three weeks ago, when the consortium realised that the biggest surge was happening in India, it raised funds and started manufacturing. So far, it has made 100 units. “We basically have the certification process in multiple countries. So far, we have only access to south India, but there is a big requirement in the north. We are trying to find somebody to collaborate with,” he says.

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