University of California San Diego (UCSD) researchers recently announced the development of a wearable ultrasound patch for continuous and noninvasive blood pressure monitoring.
They say the patch passed rigorous and comprehensive clinical validation for safety and performance on over 100 patients in a variety of settings. Their work was published Nov. 20 in the journal Nature Biomedical Engineering.
Next, the research team plans large-scale clinical trials. They want to integrate machine learning to improve the device’s capabilities further, and to validate a wireless, battery-powered version for longterm use and easy integration with existing hospital systems.
“Traditional blood pressure measurements with a cuff, which are limited to providing one-time blood pressure values, can miss critical patterns. Our wearable patch offers a continuous stream of blood pressure waveform data, allowing it to reveal detailed trends in blood pressure fluctuations,” study co-first author Sai Zhou, a recent PhD graduate in materials science and engineering from the UCSD Jacobs School of Engineering, said in a UCSD news release. (In October, Zhou founded CircuCare, a startup that is presently raising money as it develops a wearable ultrasound device for automated, continuous medical imaging.)
Easy-to-use and reliable blood pressure monitoring has long been a holy grail for digital health wearables. Wearables can act as electrocardiograms (ECGs) and pulse oximeters, and companies such as Abbott and Dexcom have fairly low-profile continuous glucose monitors (CGMs), but people still need to strap on a cuff for reliable blood pressure monitoring. More data will answer whether the UCSD technology truly provides an answer. (Wondering if your blood pressure monitor is reliable enough? The American Medical Association supports a validated blood pressure device database that is available online.)
The UCSD researchers’ blood pressure monitoring patch is a soft and stretchy device about the size of a postage stamp that adheres to the skin. When worn on the forearm, it provides precise, real-time blood pressure readings from deep within the body, according to UCSD.
The patch is made of a silicone elastomer that houses an array of small piezoelectric transducers sandwiched between stretchable copper electrodes. The transducers transmit and receive ultrasound waves that track changes in the diameter of blood vessels. The readings then get converted into blood pressure values.
How the UCSD team created the wearable blood pressure monitor
The wearable ultrasound patch improves on an earlier prototype from the lab of UCSD chemical and nanoengineering professor Sheng Xu. According to UCSD, researchers re-engineered the patch with two important improvements to boost continuous blood pressure monitoring performance:
They packed the piezoelectric transducers closer together to enable wider coverage to better target smaller arteries, such as the brachial and radial arteries, which are more clinically relevant.
A backing layer dampened redundant vibrations from the transducers, improving signal clarity and tracking accuracy of arterial walls.
More on the wearable blood pressure monitor’s clinical validation
Testing out the new patch, the UCSD researchers say they were able to produce blood pressure monitoring results that were comparable to a blood pressure cuff as well as an arterial line, which is a sensor inserted into an artery to monitor blood pressure continuously.
The researchers’ clinical validation studies tested the patch’s safety and accuracy among 117 people engaged in various activities, according to UCSD. Settings included at home, an outpatient clinic, a cath lab, and an ICU.
In one set of tests, seven participants wore the patch during daily activities, including cycling, raising an arm or leg, performing mental arithmetic, meditating, eating meals and consuming energy drinks. In a larger cohort of 85 subjects, the patch was tested during changes in posture, such as transitioning from sitting to standing. The UCSD researchers say the results from the patch closely matched those from blood pressure cuffs in all tests.
In addition, the patch’s continuous blood pressure monitoring was evaluated in 21 patients in a cardiac catheterization laboratory and four patients who were admitted to the intensive care unit after surgery. Measurements from the patch agreed closely with results from the arterial line, showcasing its potential as a noninvasive alternative, according to the UCSD researchers.
“A big advance of this work is how thoroughly we validated this technology, thanks to the work of our medical collaborators,” Xu said. “Blood pressure can be all over the place depending on factors like white coat syndrome, masked hypertension, daily activities or use of medication, which makes it tricky to get an accurate diagnosis or manage treatment. That’s why it was so important for us to test this device in a wide variety of real-world and clinical settings. Many studies on wearable devices skip these steps during development, but we made sure to cover it all.”