Fetal monitoring device and methods

• US 9,078,582 B2
• Filed: 09/27/2011
• Issued: 07/14/2015
• Est. Priority Date: 04/22/2009
• Status: Active Grant

• Current Assignee: LifeWave Biomedical, Inc.
• Original Assignee: LifeWave Biomedical, Inc.
• Inventors: Tupin, Joe Paul Jr., Tupin, Joe Paul, Stephansen, Stephan IV
• Primary Examiner(s): TURCHEN, ROCHELLE DEANNA
• Application Number:
  US13/246,784
• Publication Number:
  US 20120041281A1
• Time in Patent Office: 1,386 Days
• Field of Search: 600/407, 600/481, 600/301, 128/920
• US Class Current: 1/1
• CPC Class Codes: A61B 2503/02 Foetus
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/02411 of foetuses
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/344 Foetal cardiography
• 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 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 8/565 involving data transmission via a network
• CPC Class Codes: G01S 13/0209 Systems with very large relative bandwidth, i.e. larger than 10 %, e.g. baseband, pulse, carrier-free, ultrawideband
• CPC Class Codes: G01S 13/56 for presence detection presence detection using near field arrangements G01V3/00, e.g. G01V3/08, G01V3/12; burglar, theft or intruder alarms with electrical actuation G08B13/22 - G08B13/26
• CPC Class Codes: G01S 13/88 Radar or analogous systems specially adapted for specific applications electromagnetic prospecting or detecting of objects, e.g. near-field detection, G01V3/00

Abstract

Described herein are fetal and/or maternal monitoring devices, systems and methods using UWB medical radar. These devices and systems may include a UWB sensor providing high-resolution and reliable simultaneous monitoring of multiple indicators of fetal and/or maternal health, such as fetal heart rate, fetal heart rate variability, fetal respiration, fetal gross body movement, maternal contractions, maternal heart rate, maternal respiration, and other derivative parameters during virtually all stages of pregnancy and during delivery. The sensor allows novel collection of physiological data using a single sensor or multiple sensors to develop individual and aggregate normal motion indices for use in determining when departure from normal motion index is indicative of fetal or maternal distress.

Claims

1. An ultra-wideband (UWB) fetal monitoring system capable of concurrent monitoring of indicators of fetal and maternal health, the system comprising:

a sensor configured to transmit a UWB signal and receive reflected UWB signal data, the sensor comprising at least one antenna; and

a signal processor configured to receive the reflected UWB signal data from the sensor, wherein the signal processor is programmed to;

process the reflected UWB signal data into a matrix of reflected UWB signals indexed by depth and time,

identify which reflected UWB signals in the matrix of reflected UWB signals correspond to a uterine contraction,

differentiate between fetal and maternal regions within the matrix of reflected UWB signals based on the identification of which reflected UWB signals correspond to the uterine contraction,

extract one or more indicators of fetal health from the fetal region within the matrix of reflected UWB signals, and

extract one or more indicators of maternal health from the maternal region within the matrix of reflected UWB signals; and

a transmitted energy level adapter configured to adjust the energy level of the UWB signal transmitted by the sensor based on the energy level of the signals reflected by the fetus,

wherein the transmitted energy level adapter comprises a comparator configured to compare the energy level of signals reflected by the fetus to a predetermined target energy level, further wherein the transmitted energy level adapter is configured to adjust the energy level of the UWB signal to keep the energy level of signals reflected by the fetus within the predetermined target energy level.

2. The system of claim 1, wherein the sensor comprises a receiving antenna and a transmission antenna.

3. The system of claim 1, wherein the sensor comprises a combined antenna configured for receiving and for transmission.

4. The system of claim 1, further comprising a plurality of sensors each configured for receiving and transmission of UWB data and comprising at least one antenna.

5. The system of claim 4 configured for monostatic operation, wherein the transmission of the UWB signal from each sensor is received by the same sensor.

6. The system of claim 4 configured for multistatic operation, wherein the transmission of the UWB signal from one sensor is received by a different sensor.

7. The system of claim 1, wherein the signal processor is configured to determine one or more indicators of fetal health selected from the group consisting of:

fetal heart rate, fetal heart rate variability, fetal respiration, fetal body movement.

8. The system of claim 1, wherein the signal processor is configured to determine one or more indicators of maternal health selected from the group consisting of:

maternal heart rate, maternal contraction rate, maternal blood pressure, maternal respiration.

9. The system of claim 1, further comprising a receiver connected to the antenna, the receiver configured to receive reflections of emitted signals received by the antenna and process them into data to be passed on to the signal processor.

10. The system of claim 9, wherein the receiver is configured to amplify signals based on their depth so that signals reflected further from the sensor are amplified more than signals reflected closer to the sensor.

11. The system of claim 1, wherein the signal processor is configured to determine fetal heart rate from the fetal region within the matrix of reflected UWB signals and uterine contraction rate from the maternal region within the matrix of reflected UWB signals.

12. The system of claim 1, further comprising a local memory for storing the matrix information.

13. The system of claim 1, further comprising a communication circuit for communicating to a monitoring system.

14. The system of claim 13, wherein the monitoring system comprises a computer system configured to store and transmit data.

15. The system of claim 13, wherein the monitoring system comprises a networked server.

16. The system of claim 1, wherein the sensor is configured as a single-use, disposable sensor configured to couple and uncouple from the signal processor.

17. The system of claim 1, further comprising a non-UWB sensor.

18. The system of claim 17, wherein the non-UWB sensor comprises an accelerometer.

19. The system of claim 1, further comprising an output configured to present the one or more extracted indicators of fetal or fetal and maternal health.

20. The system of claim 19, wherein the output is configured to present at least one of the extracted indictors as a chart recording.

26. The system of claim 1, wherein the signal processor is further programmed to apply a peak detection algorithm on the matrix of reflected UWB signals to identify which reflected UWB signals correspond to a uterine contraction.

21. An ultra-wideband (UWB) fetal monitoring system capable of concurrent monitoring of indicators of fetal and maternal health, the system comprising:

a sensor configured to transmit a UWB signal and receive reflected UWB data, the sensor comprising at least one antenna;

a transmitter connected to the antenna, the transmitter configured to generate a series of low voltage, short-duration broadband pulses for transmission as an emitted signal from the antenna as an ultra-wide band spectrum signal; and

a signal processor configured to receive the reflected UWB data from the sensor, wherein the signal processor is programmed to;

process the reflected UWB signal data into a matrix of reflected UWB signals indexed by depth and time,

identify which reflected UWB signals in the matrix of reflected UWB signals correspond to a uterine contraction,

differentiate between fetal and maternal regions within the matrix of reflected UWB signals based on the identification of which reflected UWB signals correspond to the uterine contraction,

extract one or more indicators of fetal health from the fetal region within the matrix of reflected UWB signals, and

extract one or more indicators of maternal health from the maternal region within the matrix of reflected UWB signals; and

a transmitted energy level adapter configured to adjust the energy level of the UWB signal transmitted by the sensor based on the energy level of the signals reflected by the fetus,

wherein the transmitted energy level adapter comprises a comparator configured to compare the energy level of signals reflected by the fetus to a predetermined target energy level, further wherein the transmitted energy level adapter is configured to adjust the energy level of the UWB signal to keep the energy level of signals reflected by the fetus within the predetermined target energy level.

22. An ultra-wideband (UWB) fetal monitoring system for monitoring indicators of fetal and maternal health, the system comprising:

a sensor configured to transmit a UWB signal and receive reflected UWB data, the sensor comprising at least one antenna, a power source and a transmitter configured to generate a series of low voltage, short-duration broadband pulses for transmission as an emitted signal from the antenna as an ultra-wide band spectrum signal; and

a communications device configured to receive information from the sensor and to pass the information on to a signal processor, wherein the signal processor is programmed to;

process the reflected UWB signal data into a matrix of reflected UWB signals indexed by depth and time,

identify which reflected UWB signals in the matrix of reflected UWB signals correspond to a uterine contraction,

differentiate between fetal and maternal regions within the matrix of reflected UWB signals based on the identification of which reflected UWB signals correspond to the uterine contraction,

extract one or more indicators of fetal health from the fetal region within the matrix of reflected UWB signals, and

extract one or more indicators of maternal health from the maternal region within the matrix of reflected UWB signals; and

a transmitted energy level adapter configured to adjust the energy level of the UWB signal transmitted by the sensor based on the energy level of the signals reflected by the fetus,

wherein the transmitted energy level adapter comprises a comparator configured to compare the energy level of signals reflected by the fetus to a predetermined target energy level, further wherein the transmitted energy level adapter is configured to adjust the energy level of the UWB signal to keep the energy level of signals reflected by the fetus within the predetermined target energy level.

23. The system of claim 22 wherein the signal processor is configured to determine fetal heart rate and maternal contraction rate from the matrix.

24. The system of claim 22, further comprising an output configured to display one or more of the plurality of indicators of fetal or maternal health.

25. The system of claim 22, further comprising a charging cradle configured to charge the power source.