A new pill-sized device that monitors breathing from inside the stomach has come through the first human clinical trials successfully.
The ingestible device has been designed so that it can safely monitor vital signs such as breathing and heart rate from inside the body.
Scientists say the tool, described in the journal Device, has the potential to provide convenient care for people at risk of opioid overdose.
The team hopes to expand its use to monitor other health issues such as sleeping problems.
Study first author Professor Giovanni Traverso, of Massachusetts Institute of Technology (MIT), said: “The stomach generally offers some of the best signals, mainly because it’s close to the heart and the lungs, but we know that we can also sense them elsewhere.
“The ability to facilitate diagnosis and monitor many conditions without having to go into a hospital can provide patients with easier access to healthcare and support treatment.”
Unlike implantable devices such as pacemakers, ingestible devices are easy to use and do not require a surgical procedure. For example, doctors have been using pill-sized ingestible cameras to conduct colonoscopies, a procedure traditionally conducted in hospitals.
Co-author Benjamin Pless, founder of Celero Systems – a medical device developer based in Massachusetts, said: “The idea of using an ingestible device is that a physician can prescribe these capsules, and all the patient needs to do is to swallow it.
“People are accustomed to taking pills, and costs of using ingestible devices are much more affordable than performing traditional medical procedures.”
He explained that the vitals-monitoring pill, or VM Pill, works by monitoring the small vibrations of the body associated with breathing and the beating heart.
The pill can detect if a person stops breathing from the inside of the digestive tract.
To test out the VM Pill, the research team placed the device in the stomach of pigs which were put under anesthesia.
The team then administered the pigs with a dose of fentanyl that caused the pig to stop breathing, which is what happens during fentanyl overdose in humans.
The device measured the pig’s breathing rate in real-time and alerted the researchers, who were able to reverse the overdose.
The team also tested the device in humans for the first time by giving the VM Pill to those being evaluated for sleep apnoea: a disorder in which breathing repeatedly stops and starts during sleep.
The patients did not show any adverse effects from the capsule, which passed harmlessly through the digestive tract.
Pless said: “Given our interest in opioid safety, it came to our attention that sleep apnoea has a lot of the same symptoms as opioid-induced respiratory depression.”
Researchers gave the VM Pill to 10 patients with sleep apnoea at West Virginia University.
The device was able to detect when the participants’ breathing stopped and to monitor respiration rate with an accuracy of 92.7 percent.
Compared with external vital monitoring machines, the pill can monitor heart rate with an accuracy of at least 96 percent.
The trial also showed the device is safe, and all participants excreted the device in the few days after the experiment.
Co-author Dr Ali Rezai, a neuroscientist at the Rockefeller Neuroscience Institute, West Virginia University, said: “The accuracy and correlation of these recordings were excellent compared to the clinical gold standard studies we performed in our sleep laboratories.”
He added: “The ability to remotely monitor critical vital signals from patients without wires, leads, or need of medical technicians, opens the door for monitoring patients in their natural environments versus the clinic or the hospital setting.”
Traverso says the current version of the VM Pill passes through the body in about a day, but there are modifications they can make to the device in the future that would allow it to stay longer for long-term monitoring.
The team hope to upgrade the device so it can deliver drugs to reverse conditions such as opioid overdose automatically once the device detects symptoms.
Traverso, who is also a gastroenterologist at Brigham and Women’s Hospital, added: “In the future, there are many situations, including opioid overdose and other respiratory and cardiac conditions, that could certainly benefit from this ingestible device.”
Produced in association with SWNS Talker