Systems, devices, and methods for performing trans-abdominal fetal oximetry and/or trans-abdominal fetal pulse oximetry using a fetal heartbeat signal

• US 9,968,286 B2
• Filed: 09/08/2017
• Issued: 05/15/2018
• Est. Priority Date: 12/30/2015
• Status: Active Grant

• Current Assignee: Raydiant Oximetry, Inc.
• Original Assignee: Raydiant Oximetry, Inc.
• Inventors: Ray, Neil Padharia
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Liu, Chu Chuan (JJ)
• Application Number:
  US15/698,954
• Publication Number:
  US 20180070871A1
• Time in Patent Office: 249 Days
• CPC Class Codes: A61B 5/0011 Foetal or obstetric data
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/02411 of foetuses
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/1464 specially adapted for foetal tissue
• CPC Class Codes: A61B 5/1482 specially adapted for foetal tissue
• CPC Class Codes: A61B 5/4356 Assessing uterine contractions A61B5/033 takes precedence
• CPC Class Codes: A61B 5/4362 Assessing foetal parameters
• CPC Class Codes: A61B 8/02 Measuring pulse or heart rate
• CPC Class Codes: A61B 8/0866 involving foetal diagnosis; pre-natal or peri-natal diagnosis of the baby
• CPC Class Codes: A61B 8/4483 characterised by features of the ultrasound transducer
• CPC Class Codes: A61B 8/488 involving Doppler signals
• CPC Class Codes: A61B 8/56 Details of data transmission or power supply

Abstract

Light reflected from a pregnant woman'"'"'s abdomen and fetus contained therein that has been received by a detector and converted into a reflected electronic signal may be received by a processor. A portion of the reflected electronic signal that is reflected from the fetus may be isolated and the isolated portion of the reflected electronic signal may be analyzed to determine a fetal hemoglobin oxygen saturation level of the fetus. The isolation may be achieved by synchronizing the reflected electronic signal with a fetal heartbeat signal and multiplying the synchronized reflected electronic signal by the synchronized fetal heartbeat signal.

Claims

1. A system for determining a fetal hemoglobin oxygen saturation level comprising:

a light source adapted to project light into the abdomen of a pregnant mammal toward a fetus contained therein;

a detector adapted to detect light reflected from the pregnant mammal'"'"'s abdomen and the fetus contained therein over a first time domain, convert the detected light into a reflected electronic signal, and communicate the reflected electronic signal to a processor;

the processor, the processor being configured to;

receive the reflected electronic signal from the detector;

isolate a portion of the reflected electronic signal that is reflected from the fetus, the isolation comprising;

receiving a fetal heartbeat signal for the fetus from a fetal heartbeat monitor over a second time domain, the fetal heartbeat signal indicating when, in the second time domain, a fetal heartbeat occurs;

synchronizing the reflected electronic signal and the fetal heartbeat signal over the first time domain and the second time domain; and

multiplying the synchronized reflected electronic signal by the synchronized fetal heartbeat signal;

analyze the isolated portion of the reflected electronic signal to determine a fetal hemoglobin oxygen saturation level of the fetus; and

provide an indication of the oxygen level of fetal blood to a display device.

2. The system of claim 1, further comprising:

an adjustment mechanism coupled to the light source, the adjustment mechanism being adapted to adjust a frequency of light emitted by the light source.

3. The system of claim 1, further comprising:

an adjustment mechanism coupled to the light source, the adjustment mechanism being adapted to adjust an incident angle of the light emitted by the light source when the light is projected into the pregnant mammal'"'"'s abdomen.

4. The system of claim 1, further comprising:

an adjustment mechanism coupled to the light source, the adjustment mechanism being adapted to focus a beam of light as it is projected into the pregnant mammal'"'"'s abdomen as it emitted from the light source.

5. The system of claim 1, further comprising:

a housing adapted to house the light source and the detector.

6. The system of claim 1, wherein the light source and the detector are configured to be disposable following a single use thereof.

7. The system of claim 1, further comprising:

an additional detector, the additional detector being adapted to detect light reflected from the pregnant mammal'"'"'s abdomen and the fetus, convert the detected light into an additional reflected electronic signal, and communicate the additional reflected electronic signal to the processor.

8. The system of claim 1, further comprising:

an additional light source adapted to project light into the abdomen of the pregnant mammal toward the fetus contained therein.

9. The system of claim 1, wherein the light source emits a light of a wavelength within a range at least one of between 700 nm and 740 nm and between 800 and 900 nm.

10. The system of claim 1, further comprising:

a temperature probe adapted to measure a temperature of the pregnant mammal'"'"'s abdomen and communicate the temperature measurement to the processor.

11. The system of claim 1, further comprising:

an ultrasonic detector adapted to detect ultrasonic emissions of the pregnant mammal'"'"'s abdomen and fetus caused by transient thermoelastic expansion resultant from an interaction of the pregnant mammal'"'"'s abdomen and the fetus'"'"' tissue to light emitted from the light source and communicate a signal corresponding to the detected ultrasonic emissions to the processor.

12. The system of claim 1, further comprising:

a uterine contraction measurement adapted to measure changes in a muscular state of the pregnant mammal'"'"'s uterus and communicate these measurements to the processor.

13. The system of claim 1, further comprising:

a transceiver communicatively coupled the detector and/or the processor, the transceiver being adapted to receive the reflected electronic signal from the detector and communicate the received reflected electronic signal to the processor.

14. The system of claim 1, further comprising:

a receiver communicatively coupled to the detector, the fetal heart monitor, and the processor, the receiver being configured to receive a fetal heartbeat signal from a fetal heart rate monitor and a reflected electronic signal from a detector, the reflected electronic signal corresponding to light reflected from a pregnant mammal'"'"'s abdomen and a fetus contained that has been converted, by the detector, into the reflected electronic signal.

15. The system of claim 1, further comprising:

a power source electrically coupled to the light source and the detector.

16. A method for determining a fetal hemoglobin oxygen saturation level comprising:

receiving, by a processor, a fetal heartbeat signal from a fetal heart rate monitor and an reflected electronic signal from a detector, the reflected electronic signal corresponding to light reflected from a pregnant mammal'"'"'s abdomen and a fetus contained therein over a first time domain, wherein the reflected light has been converted, by the detector, into the reflected electronic signal;

processing, by the computer, the reflected electronic signal to isolate a portion of the reflected electronic signal reflected from the fetus, the processing of the reflected electronic signal comprising;

receiving a fetal heartbeat signal for the fetus over a second time domain, the fetal heartbeat signal indicating when, in the second time domain, a fetal heartbeat occurs;

synchronizing the reflected electronic signal and the fetal heartbeat signal over the first time domain and the second time domain; and

multiplying the synchronized reflected electronic signal by the synchronized fetal heartbeat signal;

analyzing, by the computer, the portion of the reflected electronic signal reflected from the fetus to determine a fetal hemoglobin oxygen saturation level of the fetus; and

facilitating, by the computer, provision of an indication of the fetal hemoglobin oxygen saturation level to an operator.

17. The method of claim 16, wherein the light directed into the pregnant woman'"'"'s abdomen has a plurality of wavelengths.

18. The method of claim 16, further comprising:

adjusting a frequency of light emitted by the light source.

19. The method of claim 16, further comprising:

adjusting an incident angle of the light emitted by the light source when projected into the pregnant mammal'"'"'s abdomen.

20. The method of claim 16, further comprising:

adjusting a focus of a beam of light as it is projected into the pregnant mammal'"'"'s abdomen as it emitted from the light source.

21. The method of claim 16, further comprising:

determining whether the reflected electronic signal is of sufficient strength; and

adjusting the light source responsively to a determination that the reflected electronic signal is not of sufficient strength.

22. The method of claim 16, further comprising:

determining whether the reflected electronic signal is of sufficient strength; and

adjusting the detector responsively to a determination that the reflected electronic signal is not of sufficient strength.

23. The method of claim 16, wherein the light is directed into the pregnant mammal'"'"'s abdomen from a plurality of sources.

24. The method of claim 16, further comprising:

receiving, by a receiver communicatively coupled to the processor, the fetal heartbeat signal and the reflected electronic signal prior to receipt of the fetal heartbeat signal and the reflected electronic signal by the computer; and

communicating the fetal heartbeat signal and the reflected electronic signal to the computer.

25. A computer for determining a fetal hemoglobin oxygen saturation level comprising:

a processor, the processor being configured to;

receive a reflected electronic signal from a detector communicatively coupled to the processor, the reflected electronic signal corresponding to light reflected from a pregnant mammal'"'"'s abdomen and a fetus contained therein over a first time domain, wherein the light has been converted, by the detector, into the reflected electronic signal;

isolate a portion of the reflected electronic signal that is reflected from the fetus, the isolation comprising;

receiving a fetal heartbeat signal for the fetus from a fetal heartbeat monitor over a second time domain, the fetal heartbeat signal indicating when, in the second time domain, a fetal heartbeat occurs;

synchronizing the reflected electronic signal and the fetal heartbeat signal over the first time domain and the second time domain; and

multiplying the synchronized reflected electronic signal by the synchronized fetal heartbeat signal;

analyze the isolated portion of the reflected electronic signal to determine a fetal hemoglobin oxygen saturation level of the fetus; and

provide an indication of the oxygen level of fetal blood to a display device.

26. The computer of claim 25, wherein the processor is further configured to:

determine whether the reflected electronic signal is of sufficient strength; and

provide an indication that the signal is not of sufficient strength to an operator responsively to a determination that the reflected electronic signal is not of sufficient strength.

27. The computer of claim 25, wherein the processor is further configured to:

determine whether the reflected electronic signal is of sufficient strength; and

provide an instruction to the detector responsively to a determination that the reflected electronic signal is not of sufficient strength.

28. The computer of claim 26, wherein the processor is communicatively coupled to a light source from which the reflected signal originated, the processor being further configured to:

determine whether the reflected electronic signal is of sufficient strength; and

provide an instruction to the light source responsively to a determination that the reflected electronic signal is not of sufficient strength.