Systems, devices, and methods for performing trans-abdominal fetal oximetry and/or trans-abdominal fetal pulse oximetry

• US 9,757,058 B2
• Filed: 12/29/2016
• Issued: 09/12/2017
• 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:
  US15/393,752
• Publication Number:
  US 20170188920A1
• Time in Patent Office: 257 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 beams emitted from one or more light sources may be directed into an abdomen of a pregnant mammal toward a fetus contained therein. Some of the light may be reflected by the pregnant woman and fetus and received at a detector over a first time. A photo detector into an electronic reflected signal, which may be communicated to a computer, may then convert the received light. The electronic reflected signal may then be processed and/or analyzed to isolate a portion of the electronic reflected signal reflected from the fetus. The isolated portion of the electronic reflected signal reflected from the fetus may then be analyzed to determine a fetal hemoglobin oxygen saturation level of the fetus. An indication of the fetal hemoglobin oxygen saturation level may then be provided to an operator by way of, for example, a computer display.

Claims

1. A system comprising:

a housing configured to house a first light source, a second light source, a detector, a transceiver, and a power source;

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

the second light source adapted to project light of a second wavelength into the abdomen of the pregnant mammal toward the fetus;

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

the transceiver, the transceiver being adapted to receive the electronic reflected signal from the detector and communicate the received electronic reflected signal to a processor;

the power source electrically coupled to the first light source, the second light source, and the detector, the power source being adapted to provide electrical power to first light source, the second light source, the detector, and the transceiver; and

the processor, the processor being configured to;

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

multiplying the synchronized electronic reflected 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 at least one of the first and second light sources, the adjustment mechanism being adapted to adjust at least one of a frequency of light emitted by the respective first and second light sources, an incident angle of the light emitted by the respective first and second light sources when projected into the pregnant mammal'"'"'s abdomen, and focus a beam of light as it is projected into the pregnant mammal'"'"'s abdomen as it emitted from the respective first and second light sources.

3. The system of claim 1, further comprising:

an adjustment device coupled to the housing, the adjustment device being adapted to adjust at least one of a frequency of light emitted by the respective first and second light sources, an incident angle of the light emitted by the respective first and second light sources when projected into the pregnant mammal'"'"'s abdomen, and focus a beam of light as it is projected into the pregnant mammal'"'"'s abdomen as it emitted from the respective first and second light sources.

4. The system of claim 1, wherein the housing, first light source, second light source, detector, transceiver, and power source are configured to be disposable following a single use thereof.

5. The system of claim 1, further comprising:

an additional detector, the additional detector being positioned within the housing and coupled to the transceiver and the power source, 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 electronic reflected signal, and communicate the additional electronic reflected signal to the transceiver.

6. The system of claim 1, further comprising:

four additional light sources housed within the housing, each of the additional light sources being coupled to the power source;

an additional detector, the additional detector being positioned within the housing and coupled to the transceiver and power sources, 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 electronic reflected signal, and communicate the additional electronic reflected signal to the transceiver

wherein the housing is adapted to have a length of at least 10cm so as to extend around a portion of the pregnant mammal'"'"'s abdomen and direct light at two sides of the fetus, further wherein the detector is positioned on a first side of the housing and the additional detector is positioned on a second side of the housing and the additional light sources are positioned between the first and second sides of the housing.

7. The system of claim 1, wherein the first light source emits a light of a wavelength between 700 nm and 740 nm and the second light source emits a light of a wavelength between 800 and 900 nm.

8. The system of claim 1, further comprising:

a temperature probe, the temperature probe being housed within the housing and coupled to the power supply and transceiver, the temperature probe being adapted to measure a temperature of the pregnant mammal'"'"'s abdomen and communicate the temperature measurements to the transceiver.

9. The system of claim 1, further comprising:

an ultrasonic detector, the ultrasonic detector being housed within the housing and coupled to the power supply and transceiver, the ultrasonic detector being 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 at least one of the first light source and the second light source.

10. The system of claim 1, further comprising:

a uterine contraction measurement device, the uterine contraction measurement being housed within the housing and coupled to the power supply and transceiver, the uterine contraction measurement being adapted to measure changes in a muscular state of the pregnant mammal'"'"'s uterus and communicate these measurements to the transceiver.

11. A method comprising:

directing, by a light source, a light beam emitted from the light source into an abdomen of a pregnant mammal toward a fetus contained therein;

receiving light reflected by the pregnant mammal and the fetus at a detector over a first time domain;

converting, by the detector, the received light into an electronic reflected signal;

communicating, by the detector, the electronic reflected signal to a computer;

processing, by the computer, the electronic reflected signal to isolate a portion of the electronic reflected signal reflected from the fetus, the processing of the electronic reflected 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 electronic reflected signal and the fetal heartbeat signal over the first time domain and the second time domain; and

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

analyzing, by the computer, the portion of the electronic reflected 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.

12. The method of claim 11, wherein the light directed into the pregnant woman'"'"'s abdomen has a plurality of wavelengths.

13. A fetal hemoglobin probe comprising:

a housing configured to house a first light source, a second light source, a detector, a transceiver, and a power source;

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

the second light source adapted to project light of a second wavelength into the abdomen of the pregnant mammal toward the fetus;

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

the transceiver, the transceiver being adapted to receive the electronic reflected signal from the detector and communicate the received electronic reflected signal to a processor;

the power source electrically coupled to the first light source, the second light source, the detector, and a controller, the power source being adapted to provide electrical power to first light source, the second light source, the detector, and the transceiver;

an adjustment mechanism coupled to at least one of the first and second light sources, the adjustment mechanism being adapted to adjust at least one wavelength of light emitted by the respective first and second light sources and an incident angle of the light emitted by the respective first and second light sources when projected into the pregnant mammal'"'"'s abdomen, and focus a beam of light as it is projected into the pregnant mammal'"'"'s abdomen as it emitted from the respective first and second light sources; and

the controller, the controller being communicatively coupled to the adjustment mechanism and at least one of the detector and the transceiver, the controller being configured to provide instructions to the adjustment mechanism that control an operation of the adjustment mechanism regarding the adjustment of the at least one wavelength of emitted light and the incident angle of the emitted light, the instructions being responsive to feedback from at least one of the detector and the transceiver regarding an aspect of the reflected light detected by the detector.

14. The fetal hemoglobin probe of claim 13, further comprising:

an adjustment device coupled to the housing, the adjustment device being adapted to adjust at least one of a frequency of light emitted by the respective first and second light sources, an incident angle of the light emitted by the respective first and second light sources when projected into the pregnant mammal'"'"'s abdomen, and focus a beam of light as it is projected into the pregnant mammal'"'"'s abdomen as it emitted from the respective first and second light sources.

15. The fetal hemoglobin probe of claim 13, wherein the housing, first light source, second light source, detector, transceiver, and power source are configured to be disposable following a single use thereof.

16. The fetal hemoglobin probe of claim 13, further comprising:

an additional detector, the additional detector being positioned within the housing and coupled to the transceiver and the power source, 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 electronic reflected signal, and communicate the additional electronic reflected signal to the transceiver.

17. The fetal hemoglobin probe of claim 13, further comprising:

four additional light sources housed within the housing, each of the additional light sources being coupled to the power source; and

an additional detector, the additional detector being positioned within the housing and coupled to the transceiver and power sources, 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 electronic reflected signal, and communicate the additional electronic reflected signal to the transceiver

wherein the housing is adapted to have a length of at least 10 cm so as to extend around a portion of the pregnant mammal'"'"'s abdomen and direct light at two sides of the fetus, further wherein the detector is positioned on a first side of the housing and the additional detector is positioned on a second side of the housing and the light sources are positioned between the first and second sides of the housing.

18. The fetal hemoglobin probe of claim 13, wherein the first light source emits a light of a wavelength between 700 nm and 740 nm and the second light source emits a light of a wavelength between 800 and 900 nm.

19. The fetal hemoglobin probe of claim 13, further comprising:

a temperature probe, the temperature probe being housed within the housing and coupled to the power supply and transceiver, the temperature probe being adapted to measure a temperature of the pregnant mammal'"'"'s abdomen and communicate the temperature measurements to the transceiver.

20. The fetal hemoglobin probe of claim 13, further comprising:

an ultrasonic detector, the ultrasonic detector being housed within the housing and coupled to the power supply and transceiver, the ultrasonic detector being 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 at least one of the first light source and the second light source.

21. The fetal hemoglobin probe of claim 13, further comprising:

a uterine contraction measurement device, the uterine contraction measurement being housed within the housing and coupled to the power supply and transceiver, the uterine contraction measurement being adapted to measure changes in a muscular state of the pregnant mammal'"'"'s uterus and communicate these measurements to the transceiver.