Copyright © Françoise Herrmann
Winner of three CES 2019 Innovation awards and Best start-up award at CES 2016, Owlet® Baby Care, Inc., is a pioneering company in the domain of wearable infant care monitoring systems. In particular, Owlet® has targeted Sudden Infant Death Syndrome (SIDS) which claims the lives of approximately 2000 babies between the ages of 1 and 12 months, in the US, each year.
The invention comprises in a wireless smart sock, which includes a miniaturized pulse oximeter and processor. A pulse oximeter is a non-invasive method of measuring blood oxygen saturation (SpO2). When an abnormal trend in blood oxygen levels is recorded and processed, a transmitter sounds an alert and sends the information to a remote server via Internet gateway, enabling the alert to also be retrieved and read on a mobile device. This invention resolves issues with the prior art of infant monitoring devices since previous infant monitors are intercom-type monitors. Intercom-type monitors include video and sound recording, designed to inform parents if there is no motion sensed or sound heard in the infant’s room. The pulse oximeter smart sock thus offers much more precise data, and an opportunity for much faster intervention, in case of an alert.
In 2018, the Owlet® sock had measured more than 1 trillion baby heartbeats! Although the device is not cleared as a medical device by the FDA, it has been tested for accuracy of readings in a clinical trial (Owlet®, Clinicaltrials.gov). The measurements of blood oxygen levels using SpO2 (Pulse oximeter saturation), compared to SaO2 (Arterial oxygen saturation, using a continuous arterial line), are in fact well correlated, and generally considered sufficiently accurate, especially for pediatric patients, considering the benefits of costs, convenience, and non-invasiveness. Pulse oximeters are also standard of care under many medical circumstances, such as anesthesia, since the 1980s. Finally, the prime motivation for the design of the Owlet® invention is highly personal. One of the founder wives was afflicted with congenital heart disease and was rescued from SIDS on intuition, resulting in emergency open heart surgery. Since such conditions are hereditary, the founder felt compelled to find a way of monitoring his own son’s health, when the couple started their own family.
This invention is recited in the WIPO patent application WO2014035836A1 titled Wireless infant health monitor and the design of the sock is patented in the US design patent USD781568S1, titled Infant sock. The abstract of the WIPO patent is included below together with the patent Figure 1, illustrating all the components of an embodiment of the invention: the sock comprising the sensing module (100), the receiving station (110) in communication with an Internet gateway (120) (e.g.; a cable modem, router, DSL modem or Ethernet port), and the mobile device (130), which can show in real time heart rate and oxygen level data captured by the sensing device (100). The sock (200) also depicted in the drawing is designed to receive the sensor, which can be used with increasingly larger socks, and removed for laundering the sock. An image of the marketed smart sock in three different colors is also included above.
A system for wirelessly monitoring the health of an infant comprising a sensing module removably disposed within a wearable article. At least a portion of the sensing module can be in contact with an infant's foot. The sensing module can include a processing unit configured to receive and process health readings received by the sensing module. A wireless transmitter can also be in communication with the processing unit. The wireless transmitter can be configured to transmit the processed health readings to a receiving station. The receiving station can indicate an alarm if the processed health readings indicate a health trend that falls outside of a particular threshold. [Abstract
References
ClinicalTRials.gov - SpO2 Accuracy Comparison of Smart Sock V. 2 SpO2 to Arterial Blood CO-Oximetry
FDA – Baby products with SIDS prevention claims
HSU, A (2011) Rethinking SIDS: Many deaths no longer a mystery
NIHCD - Safe sleep for your baby: Reduce the causes of sudden infant death syndrome (SIDS) and other sleep-related causes of infant death
Raven, R. (2018) SIDS - Sudden Infant and Early Childhood Death Syndrome: Past, Present and Future
Singh, Anupam Kumar et al. Comparative Evaluation of Accuracy of Pulse Oximeters and Factors Affecting Their Performance in a Tertiary Intensive Care Unit DOI: 10.7860/JCDR/2017/24640.9961
