Summary: 

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) seeks research co-development partners and/or licensees for clinical validation and to further develop the technology. 

Description of Technology: 

Observing the placenta during pregnancy offers a look into the utero fetal environment. Monitoring placental oxygenation level and maternal physiological signals can be useful to assess mother and fetus well-being during pregnancy. Additionally, fetal movement has long served as a measure for well-being and nervous system development helping identify adverse pregnancy outcomes. Identification of complications during pregnancy can allow for earlier interventions, including medications to reduce risk of perinatal mortality and maternal gene therapy. Current non-invasive techniques on available are considered expensive, bulky, and do not offer continuous monitoring of fetal physiological signals and placental oxygenation. There is an unmet need for a convenient way for mothers to safely monitor their pregnancy remotely. 

Researchers created a wearable, wireless device and protocol for continuously monitoring the placental oxygenation levels, multiple physiological signals and movement activities of a fetus and mother. The device includes a compact control board, flexible near-infrared spectroscopy (NIRS) probe and multiple accelerator probes. A classification algorithm based on Monte-Carlo simulations of multiple layers model computes oxygen saturation of the placenta. There is one or more accelerator probes attached to different body parts of the mother to detect mother movement activities and to eliminate the effect of mother movement on fetal movement. The overall data acquisition rate of this device is 10 Hz or more. With this acquisition rate, the output of the device contains extra physiological signal such as maternal respiratory and cardiac functions, and fetal cardiac functions. 

The NICHD seeks research co-development partners and/or licensees for clinical validation and to further develop the technology.

Potential Commercial Applications: 

• Low cost and flexible method of continuously monitoring pregnancy health
• Early identification of adverse outcomes such as reduced uteroplacental perfusion and stillbirth
• Potential for device to be applied in general health monitoring or sleep monitoring 
• Daily measurement results may be collected by a cellphone and uploaded to cloud for patient’s healthcare provider to remotely review and provide health suggestions

Competitive Advantage:

• Wearable and non-invasive placenta and fetal monitoring device
• Capable of 24/7 monitoring of mother and fetal well-being
• Low power consumption 
• Monitors both maternal and fetal multiple physiological signals and movement activities