[Federal Register Volume 88, Number 233 (Wednesday, December 6, 2023)]
[Notices]
[Pages 84823-84824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26736]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government Owned Inventions

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The invention listed below is directed to a device to measure 
placental oxygen saturation in pregnant women from 20 weeks of 
pregnancy to delivery. The device monitors maternal tissue oxygen 
saturation, blood oxygen saturation, breathing rate, heart rate, and 
heart rate variability from signal, fetal movement activity and 
potentially fetal heart rate and heart rate variability. This 
technology was discovered and is being developed by the National 
Institute on Child Health and Human Development (NICHD). The NICHD is 
currently seeking a licensee and/or collaborator to further develop 
this technology.

FOR FURTHER INFORMATION CONTACT: Inquiries related to this licensing 
and collaboration opportunity should be directed to: Zarpheen Jinnah, 
Technology Transfer Manager, NCI Technology Transfer Center, 9609 
Medical Center Drive, RM 1E530, MSC 9702, Bethesda, MD 20892-9702 (for 
business mail), Rockville, MD 20850-9702. Telephone: (240)-276-5530;

[[Page 84824]]

Facsimile: (240)-276-5504; Email: [email protected]. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
unpublished information related to this invention.

SUPPLEMENTARY INFORMATION: The following patent application is 
available for licensing and/or collaboration under a Cooperative 
Research and Development Agreement (CRADA):
    US Provisional Application No. 63/451,066.
    Achieving expeditious commercialization of federally funded 
research and development is consistent with the goals of the Bayh-Dole 
Act, codified as 35 U.S.C. 200-212.

Background and Description of Technology

    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 fetal well-being and nervous system development helping to 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. 
Researchers at NICHD have created a wearable and 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, a 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 are 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.

Potential Commercial Applications

    A low cost wearable device, similar to a smart watch, in which a 
pregnant woman can wear regularly to monitor both mother and fetus 
health conditions.
    Competitive Advantages:
     Wearable and non-invasive placenta and fetal monitoring 
device.
     Capable of 24/7 continuous monitoring of mother and fetal 
well-being.

Development Stage

    Clinical development.

    Dated: November 30, 2023.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2023-26736 Filed 12-5-23; 8:45 am]
BILLING CODE 4140-01-P