NONINVASIVE MEASUREMENT OF UTERINE EMG PROPAGATION AND POWER SPECTRUM FREQUENCY TO PREDICT TRUE PRETERM LABOR AND DELIVERY

• US 20110237972A1
• Filed: 03/23/2011
• Published: 09/29/2011
• Est. Priority Date: 03/23/2010
• Status: Abandoned Application

• Current Assignee: Reproductive Research Technologies, LP
• Original Assignee: Reproductive Research Technologies, LP
• Inventors: Garfield, Robert, Fink, Rainer J., McCrary, Jack N.
• Application Number:
  US13/069,738
• Publication Number:
  US 20110237972A1
• Time in Patent Office: Days
• US Class Current: 600/546
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/391 of genito-urinary organs
• CPC Class Codes: A61B 5/397 Analysis of electromyograms
• CPC Class Codes: A61B 5/4356 Assessing uterine contractions A61B5/033 takes precedence
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

A method operable to more accurately predict true preterm labor and delivery is provided. Trans-abdominal uterine electromyography (EMG) and power spectrum (PS) analysis can identify electrical signals characteristic of labor at term and preterm with relatively high positive and negative predictive values. The use of propagation velocity (PV) of uterine EMG signals may either be done independently or in conjunction with PS analysis. This method involves applying at least two pairs of electrodes to a maternal abdomen. The time associated with measuring a voltage spike of a propagating myometrial wave traveling through the pairs of electrodes allows the amount of time required for the propagating myometrial wave to transverse the distance between electrodes to be determined. With this information a propagation velocity (PV) of the propagating myometrial wave may be determined. This PV may be compared to a labor positive predictive value (PPV). A favorable comparison indicates an increased probability of true preterm labor and delivery.

Claims

1. A method operable to predict True Preterm Labor and Delivery comprising:

applying at least two pairs of electrodes to a maternal abdomen;

measuring a first time associated with a voltage spike of a propagating myometrial wave traveling through a first electrode pair of the at least two pairs of electrodes;

measuring a second time associated with the voltage spike of the propagating myometrial wave traveling through a second electrode pair of the at least two pairs of electrodes

determining an amount of time (T) required for the propagating myometrial wave to traverse a distance (D) between the first and the second electrode pairs;

calculating a propagation velocity (PV) of the propagating myometrial wave; and

comparing the PV of the propagating myometrial wave to a labor positive predictive value (PPV) PV, wherein a favorable comparison between the PPV PV and the calculated PV indicates an increased probability of True Preterm Labor and Delivery.

2. The method of claim 1, wherein the at least two pairs of electrodes detect a uterine electromyography (EMG) signal associated with the propagating myometrial wave.

3. The method of claim 1, wherein the amount of time is determined by a time difference associated with the voltage spikes detection at the at least two pairs of electrodes attached to a maternal abdomen.

4. The method of claim 1, wherein the increased probability of True Preterm Labor and Delivery results in delivery within a predefined number of days.

5. The method of claim 1, further comprising measuring a power spectrum (PS) signal of the propagating myometrial wave.

6. The method of claim 5, wherein the PS signal is analyzed from about 0.34 to 1.00 Hz.

7. The method of claim 5, wherein the PS signal is analyzed for:

PS peak and median frequency;

PS peak and median amplitude;

burst duration;

interburst interval duration; and

standard deviation of burst and interburst interval duration.

8. The method of claim 1, wherein calculating the PV of the propagating myometrial wave comprises dividing the distance (D) that the propagating myometrial wave travels by the amount of time (T).

9. The method of claim 1, further comprising matching a skin impedance associated with the maternal abdomen.

10. The method of claim 1, wherein an unfavorable comparison between the PPV PV and the calculated PV indicates a decreased probability of True Preterm Labor and Delivery.

11. A system operable to predict True Preterm Labor and Delivery, the system comprising:

at least two pairs of electrodes in communication with a maternal abdomen, the pairs of electrodes operable to acquire raw uterine electromyography (EMG) signals associated with a propagating myometrial wave;

a signal processing module communicably coupled to the pairs of electrodes, the signal processing module operable to;

filter and amplify the raw uterine EMG signals;

obtain a processed EMG signal;

calculate a propagation velocity (PV) of the propagating myometrial wave based on the processed EMG signal and a known location of the pair of electrodes;

comparing the PV of the propagating myometrial wave to a labor positive predictive value (PPV) PV, wherein a favorable comparison between the PPV PV and the calculated PV indicates an increased probability of True Preterm Labor and Delivery; and

display a communication indicating the increased probability of True Preterm Labor and Delivery.

12. The system of claim 11, further comprising a skin impedance matching system, the skin impedance matching system operable to correct the processed EMG signal for a skin impedance associated with the a maternal abdomen.

13. The system of claim 12, the skin impedance matching system comprising:

a matching module configured to determine the skin impedance by sensing an input impedance from the patient through the pair of electrodes, and amplifying and digitizing the input impedance;

a resistor ladder network configured to match the skin impedance using at least one resistor;

a microprocessor configured to analyze the input impedance and generate a series of control signals to direct the resistor ladder network to match the skin impedance; and

a sensing module configured to sense uterine EMG signals from the patient through the pair of electrodes in conjunction with the resistor ladder network.

14. The system of claim 13 in which the resistor ladder network matching is accomplished through a software calibration factor.

15. The system of claim 14, wherein the sensing module is communicably coupled to the signal processing module.

16. The system of claim 11, wherein signal processing module is operable to determine an amount of time (T) required for the propagating myometrial wave to traverse a distance (D) between the pair of electrodes in communication with a maternal abdomen, the amount of time is determined by a time difference associated with the voltage spikes at the at least two pairs of electrodes.

17. The system of claim 11, wherein the increased probability of True Preterm Labor and Delivery results in delivery within a predefined number of days.

18. The system of claim 11, further comprising a sensing module operable to measure a power spectrum (PS) signal of the propagating myometrial wave.

19. The system of claim 18, wherein the PS signal is analyzed from about 0.34 to 1.00 Hz.

20. The system of claim 18, wherein the PS signal is analyzed for:

PS peak and median frequency;

PS peak and median amplitude;

burst duration;

interburst interval duration; and

standard deviation of burst and interburst interval duration.

21. The system of claim 11, wherein calculating the PV of the propagating myometrial wave comprises dividing the distance (D) that the propagating myometrial wave travels by the amount of time (T).

22. The system of claim 11, further comprising matching a skin impedance associated with the maternal abdomen.

23. The system of claim 11, wherein an unfavorable comparison between the PPV PV and the calculated PV indicates a decreased probability of True Preterm Labor and Delivery.