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US-20260123879-A1 - SYSTEMS, DEVICES, AND METHODS FOR DETEREMINING A FETAL OXIMETRY VALUE USING AN IN VIVO FETAL OXIMETRY MODEL AND/OR AN AUGMENTED IN VIVO FETAL OXIMETRY MODEL

US20260123879A1US 20260123879 A1US20260123879 A1US 20260123879A1US-20260123879-A1

Abstract

A physiological indicator for a pregnant mammal and/or her fetus may be used to augment and/or personalize a fetal oximetry model to the pregnant mammal, the fetus, and/or the pregnant mammal/fetus pair. Light transmission data that corresponds to and/or represents a composite of light that passes through the pregnant mammal's abdomen and the fetus may be received and input into the augmented fetal in vivo fetal oximetry model. An output from the augmented fetal in vivo fetal oximetry model that includes an indication of an oximetry value and/or wellness for the fetus may be generated and/or received.

Inventors

  • Paul Stetson
  • Neil Padharia Ray
  • Adam Jacobs
  • Andrew Prescott

Assignees

  • RAYDIANT OXIMETRY, INC.

Dates

Publication Date
20260507
Application Date
20231011

Claims (20)

  1. 1 . A method comprising: receiving, by a processor, a physiological indicator for a pregnant mammal or the pregnant mammal's fetus; receiving, by the processor, light transmission data, the light transmission data corresponding to an optical signal that is detected by a photodetector and converted into the light transmission data, the optical signal being a composite of light that passes through the pregnant mammal's abdomen and a fetus disposed within the pregnant mammal's abdomen; inputting, by the processor, the light transmission data into an augmented fetal in vivo fetal oximetry model, the augmented fetal in vivo fetal oximetry model incorporating the physiological indicator; and receiving, by the processor, an output from the augmented fetal in vivo fetal oximetry model, the output including an indication of an oximetry value for the fetus.
  2. 2 . The method of claim 1 , wherein the physiological indicator for the pregnant mammal is at least one of a hemoglobin oxygen saturation level, a tissue oxygen saturation level, a skin tone, a heartrate, a blood pressure, photoplethysmogram (PPG) signals or values, pulse, respiratory rate, uterine contraction information, duration of labor and delivery of a fetus, gestational age of the fetus, chronological age of the pregnant mammal, a hemoglobin oxygen saturation level, and a tissue oxygenation level.
  3. 3 . The method of claim 1 or 2 , wherein the oximetry value is at least one of a level of fetal hemoglobin oxygen saturation and a level of fetal tissue oxygen saturation.
  4. 4 . The method of any of claims 1-3 , further comprising: determining, by the processor, a calibration formula for the pregnant mammal responsively to the physiological indicator, wherein the calibration formula is incorporated into the augmented fetal in vivo fetal oximetry model.
  5. 5 . The method of any of claims 1-4 , further comprising: determining, by the processor, an indication of fetal distress using the oximetry value for the fetus; and providing, by the processor, the indication of fetal distress to a display device.
  6. 6 . The method of any of claims 1-5 , further comprising: comparing, by the processor, the oximetry value for the fetus to a threshold fetal oximetry value; and providing, by the processor, an indication of the comparison to a display device.
  7. 7 . The method of any of claims 1-6 , further comprising: querying, by the processor, a database of calibration equations for a calibration equation correlated to the physiological indicator; receiving, by the processor, a calibration equation from the database responsively to the query, wherein the augmented fetal in vivo fetal oximetry model is personalized to the pregnant mammal or fetus using the received physiological indicator model.
  8. 8 . The method of any of claims 1-7 , further comprising: querying, by the processor, a database of physiological indicator model for a physiological indicator model correlated to the physiological indicator; receiving, by the processor, a physiological indicator model from the database responsively to the query, wherein the augmented fetal in vivo fetal oximetry model is personalized to the pregnant mammal or fetus using the received physiological indicator model.
  9. 9 . The method of any of claims 1-8 , further comprising: receiving, by the processor, a plurality of physiological indicators over time; and evaluating, by the processor, the plurality of physiological indicators, wherein the augmented fetal in vivo fetal oximetry model is personalized to the pregnant mammal using an evaluation of the received plurality of physiological indicators.
  10. 10 . The method of claim 9 , wherein each of the plurality of physiological indicators are a measurement of a physiological indicator for the pregnant mammal or fetus over time and the evaluation of the plurality of physiological indicators is a trend analysis.
  11. 11 . A method comprising: determining information regarding a blood oxygen value of a fetus, the determining comprising: obtaining at least one signal indicating light detected from a pregnant mammal's abdomen and/or a fetus disposed in the pregnant mammal's abdomen following application of light to the pregnant mammal's abdomen; and analyzing the at least one signal using a trained model personalized to the pregnant mammal to determine blood oxygen information used to determine the information regarding a blood oxygen value of the fetus, the trained model being personalized to the pregnant mammal using a physiological indicator for the pregnant mammal.
  12. 12 . The method of claim 11 , wherein the trained model is further personalized to the pregnant mammal using at least one of an optical and a geometric characteristic of the pregnant mammal's abdomen.
  13. 13 . The method of claim 11 or 12 , wherein the trained model is further personalized to the pregnant mammal using at least one of an optical and a geometric characteristic of the fetus.
  14. 14 . The method of any of claims 11-13 , wherein the trained model is further personalized to the pregnant mammal using a characteristic of the at least one signal.
  15. 15 . The method of any of claims 11-14 , wherein the trained model is further personalized to the pregnant mammal using at least one of a light scattering coefficient and a light absorption coefficient specific to the pregnant mammal.
  16. 16 . The method of any of claims 11-15 , wherein the trained model is personalized to the pregnant mammal using a skin color of the pregnant mammal's abdomen.
  17. 17 . The method of any of claims 11-16 , wherein the trained model is personalized to the pregnant mammal using an analysis of an image of the pregnant mammal's abdomen.
  18. 18 . The method of any of claims 11-17 , wherein the physiological indicator for the pregnant mammal is at least one of a hemoglobin oxygen saturation level, a tissue oxygen saturation level, a skin tone, a heartrate, a blood pressure, photoplethysmogram (PPG) signals or values, pulse, respiratory rate, uterine contraction information, duration of labor and delivery of a fetus, gestational age of the fetus, chronological age of the pregnant mammal, a hemoglobin oxygen saturation level, and a tissue oxygenation level.
  19. 19 . The method of any of claims 11-18 , wherein the trained model is personalized to the pregnant mammal using a calibration formula that is responsive to one or more characteristics of the pregnant mammal.
  20. 20 . The method of any of claims 11-19 , wherein the information regarding the blood oxygen value of the fetus is a level of fetal hemoglobin oxygen saturation.

Description

RELATED APPLICATION This application is an INTERNATIONAL application (PCT) claiming priority to U.S. Provisional Patent Application No. 63/415,269 filed on 11 Oct. 2022 and entitled “SYSTEMS, DEVICES, AND METHODS FOR DETERMINING AFETAL OXIMETRY VALUE USING AN IN VIVO FETAL OXIMETRY MODEL AND/OR AN AUGMENTED IN VIVO FETAL OXIMETRY MODEL,” which is incorporated by reference, in its entirety, herein. FIELD OF INVENTION The present invention is in the field of medical devices, oximetry, pulse oximetry, and machine learning, more particularly, in the fields using machine learning to develop a model to determine and/or predict fetal oximetry values using measured light transmission data, wherein a portion of the measured light transmission data includes light transmission data for 301 light incident on a fetus within a pregnant mammal's abdomen. The present invention is also directed to using a fetal oximetry model to determine and/or predict fetal oximetry values using measured light transmission data. BACKGROUND Current methods of monitoring fetal health, such as monitoring fetal heart rate, are inefficient and prone to inaccuracies when determining levels of fetal distress and, at times, provide false positive results indicating fetal distress that may result in the unnecessary performance of a Cesarean delivery. One area of interest in improving fetal health monitoring includes the use of transabdominal fetal oximetry. Oximetry is a method for determining a level of oxygen saturation of a mammal's tissue, arterial hemoglobin, and/or venous hemoglobin. A mammal's level of oxygen saturation may provide an indication of health or overall wellness of an individual. Transabdominal-fetal-oximetry is a method of oximetry for a fetus performed by analyzing light projected into a pregnant mammal's abdomen that reflects off the fetus contained therein and is detected by a photodetector. The optical information detected by the photodetector is analyzed to calculate fetal oximetry values that may be used to determine whether or not a fetus is in distress and/or is at risk of developing hypoxemia or hypoxia. SUMMARY Systems, devices, and methods disclosed herein may receive a physiological indicator such as a hemoglobin oxygen saturation level, a tissue oxygen saturation level, a skin tone, a heartrate, a blood pressure, photoplethysmogram (PPG) signals or values, pulse, respiratory rate, uterine contraction information, duration of labor and delivery of a fetus, gestational age of the fetus, chronological age of the pregnant mammal, a hemoglobin oxygen saturation level, and a tissue oxygenation level for a pregnant mammal or the pregnant mammal's fetus. Light transmission data that corresponds to an optical signal that is detected by a photodetector and converted into the light transmission data may be received. The optical signal may be a composite of light that passes through the pregnant mammal's abdomen and a fetus disposed within the pregnant mammal's abdomen. The light transmission data may be input into an augmented fetal in vivo fetal oximetry model that incorporates the physiological indicator as, for example, in input variable of an in vivo fetal oximetry model. In some embodiments, personalization of the fetal oximetry model may be done by determining a calibration formula for the pregnant mammal or fetus responsively to the physiological indicator and then incorporating the determined calibration formula into a fetal oximetry model. At times, determining the calibration formula may include querying a database of calibration equations for a calibration equation that matches and/or is responsive to the physiological indicator. A calibration equation may be received from the database responsively to the query and the augmented fetal in vivo fetal oximetry model may be personalized to the pregnant mammal or fetus using the received calibration equation. Additionally, or alternatively, personalization of the fetal oximetry model may be done by selecting and/or determining a physiological indicator model for the pregnant mammal or fetus responsively to the physiological indicator and then incorporating the selected and/or determined physiological indicator model into a fetal oximetry model. At times, selecting and/or determining the physiological indicator model may include querying a database of calibration equations for a physiological indicator model that matches and/or is responsive to the physiological indicator. A physiological indicator model may be received from the database responsively to the query and the augmented fetal in vivo fetal oximetry model may be personalized to the pregnant mammal or fetus using the received physiological indicator model. An output from the augmented fetal in vivo fetal oximetry model may be received. The output may include an indication of an oximetry value for the fetus such as a level of fetal hemoglobin oxygen saturation and/or a level of fetal tissue oxygen saturation. In