A tiny clothespin-like device that clips to a patient’s ear and triggers brain signals to halt massive bleeding soon could become the drugless answer for women who hemorrhage during and after childbirth — a major cause of maternal death worldwide.
Preliminary human studies of the “neural tourniquet” are under way at the Feinstein Institute for Medical Research in Manhasset. The tourniquet, which taps into the brain’s powerful forces to stop life-threatening bleeding, is the brainchild of Dr. Kevin Tracey, the institute’s director and a leading pioneer in the burgeoning field of bioelectronic medicine.
“I am very excited to see a simple idea from the laboratory bench move into clinical testing,” Tracey said Tuesday of the tourniquet.
He was aided in the device’s development by a Feinstein research team — Drs. Jared Huston and Christopher Czura and Chad Bouton, vice president of advanced engineering. They are helping to break scientific ground as they usher in a method of treatment that uses electrical impulses, not drugs. A broader range of research is planned over the next few months as the team aims for federal regulatory review.
The device uses electrical nerve stimulation to reduce blood loss and, according to the Feinstein team’s data, can control uterine bleeding. It is based on a theory that underlies similar applications of bioelectronic medicine being used to treat epilepsy, depression, and cluster headaches.
In July, medical investigators in the Netherlands demonstrated in a small study, based on Tracey’s groundbreaking research, that rheumatoid arthritis can be controlled through the bioelectronic method of stimulating the vagus nerve, which runs from the brain and branches throughout the body.
Controlling blood loss by way of the neural tourniquet clipped to an ear relies similarly on the vagus nerve and how it communicates with the body’s organs and tissues, said Tracey, a neurosurgeon by training.
“It’s neuroanatomy,” he explained. “The external ear is innervated by a branch of the vagus nerve. We knew this and took advantage of it.”
The electrical stimulation from the device moves at warp speed to the ear’s branch of the vagus nerve, from there to the brain stem and from the brain stem to the spleen. The spleen is a veritable storehouse of blood cells of all kinds, including platelets that when activated become wads of sticky discs — blood clots — that stop bleeding.
When the signal travels to the spleen, Tracey said, it is converted to a chemical signal that regulates the platelets.
Postpartum hemorrhage kills 6,000 to 8,000 women annually in this country and another 80,000 in Africa and Asia, he said.
The device and its preliminary research were announced jointly Tuesday by the Feinstein Institute, a division of the Northwell Health system, medical device-maker Sanguistat Inc., in Morris, Connecticut, and the Global Good Fund’s Intellectual Ventures in Bellevue, Washington. The Global Good Fund is a collaborative effort with billionaire philanthropist Bill Gates and supports inventions aimed at improving lives in developing countries.
By the second half of next year — after regulatory issues in the United States are satisfied — the hope is to test the device in developing nations where postpartum hemorrhaging is common, said Ronald Burch, Sanguistat’s president and chief executive.
“The neural tourniquet could represent a major breakthrough in treating bleeding,” he said. “If successful, it would have tremendously positive implications, not only for women giving birth, but also for soldiers wounded in battle, for patients in emergency rooms, and for patients with chronic bleeding diseases such as hemophilia.”
David Bell, director of Global Health Technologies at Global Good, said in a statement, “All postpartum hemorrhage deaths are tragic, but they are all too common in low-income countries, where many women suffer from anemia and lack access to the necessary obstetric care.”
Burch said while the science may seem complex, the device is small and easy to use.
“Think of it as a very small clothespin, and the tip — where the clothespin comes together — is where the electrodes are and where current runs through the ear,” he said.