Method and apparatus for analyzing uterine electrical activity from surface measurements for obstetrical diagnosis

• US 5,623,939 A
• Filed: 06/07/1995
• Issued: 04/29/1997
• Est. Priority Date: 05/19/1994
• Status: Expired due to Term

• Current Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Original Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Inventors: Garfield, Robert E.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US08/483,755
• Time in Patent Office: 692 Days
• Field of Search: 128/733, 128/738, 128/774, 128/778, 128/782
• US Class Current: 600/546
• CPC Class Codes: A61B 5/035 Intra-uterine probes therefor
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/391 of genito-urinary organs
• CPC Class Codes: A61B 5/42 Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems A61B1/00, A61B5/4857, A61B5/486, A61B5/4866, A61B5/4869 take precedence
• CPC Class Codes: A61B 5/4356 Assessing uterine contractions A61B5/033 takes precedence
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 5/7242 using integration
• CPC Class Codes: A61B 5/726 using Wavelet transforms

Abstract

A method and apparatus is presented for recording uterine electrical activity from the surface of the abdomen or vagina for the purpose of diagnosing contractile patterns of the uterus in pregnant and nonpregnant patients. The present invention provides data analysis techniques for analyzing electromyographic data measured from the surface of a patient to characterize uterine activity. The method and apparatus described include algorithms for the systematic analysis of electrical signals recorded from the abdominal surface. Such processing comprises integration of signals, frequency spectral analysis, 3-dimensional power density mesh plots, vector analysis, fast wavelet transform, and joint time-frequency characteristics. These techniques and apparatus are appropriate for use in a clinic or through communication lines for use as a remote or home uterine monitoring system. As such, uterine electrical activity may be measured at a remote location and processed at a central facility through on-line communications channels, such as a telephone line. The techniques and apparatus disclosed are also useful in predicting successful treatment for cases where either the uterus fails to develop forceful contractions at term or begins to contract pre-term.

Claims

1. A method of analyzing surface electromyographic data to characterize uterine activity, comprising:

applying action potential measuring electrodes to a surface of a patient;

measuring electromyographic signals produced by said electrodes;

analyzing frequency components of said electromyographic signals; and

characterizing uterine activity of said patient based on said analysis of frequency components.

2. The method of claim 1, further comprising:

stimulating a vagina of said patient while said electromyographic signals are being measured; and

diagnosing labor as a function of said signal analysis.

3. The method of claim 1, further comprising:

predicting treatment for said patient based on said characterization of uterine activity.

4. The method of claim 3, wherein said predicting step comprises pharmacologically inducing or inhibiting labor in said patient.

5. The method of claim 1, wherein said analyzing step further comprises isolating high frequency components (F2) within said electromyographic signals.

6. The method of claim 5, wherein said high frequency components (F2) are in the approximate range from 0.005 to 3.0 Hertz.

7. The method of claim 5, wherein said analyzing step further comprises:

isolating a fast wave component (FW) within said high frequency components (F2); and

determining a low-frequency (FW_L) domain, including low-frequency components within said fast wave component (FW), and a high-frequency (FW_H) domain, including high-frequency components within said fast wave component (FW).

8. The method of claim 7, wherein said low-frequency (FW_L) domain includes frequencies in the approximate range from 0.01 to 0.06 Hertz, and said high-frequency (FW_H) domain includes frequencies in the approximate range from 0.06 to 3.0 Hertz.

9. The method of claim 7, wherein said analyzing step further comprises determining a relationship between said low-frequency (FW_L) domain and said high-frequency (FW_H) domain indicative of an obstetrical diagnosis.

10. The method of claim 9, wherein said relationship is indicative of pre-term or term uterine activity.

11. The method of claim 7, wherein said analyzing step further comprises determining power density spectral characteristics of said frequency components of said electromyographic signals.

12. The method of claim 11, said analyzing step further comprises generating a 3-dimensional mesh plot of said power density spectral characteristics, said mesh plot displaying energy levels versus frequency versus time of pregnancy.

13. The method of claim 11, wherein said analyzing step further comprises:

creating a power density spectrum curve;

integrating said power density spectrum curved to determine an approximate total low energy for said low-frequency (FW_L) domain and an approximate total high energy for said high-frequency (FW_H) domain; and

determining a relationship between said approximate total low-energy and said approximate total high-energy indicative of an obstetrical diagnosis.

14. The method of claim 13, wherein said relationship is a ratio.

15. The method of claim 13, wherein said relationship is indicative of pre-term or term uterine activity.

16. The method of claim 1, wherein said analyzing step further comprises determining fast wavelet transform characteristics of said frequency components of bursts of action potentials within said electromyographic signals.

17. The method of claim 1, wherein said analyzing step further comprises determining joint time-frequency characteristics of said frequency components of bursts of action potentials within said electromyographic signals.

18. A method of analyzing surface electromyographic data to characterize uterine activity, comprising:

applying a plurality of action potential measuring electrodes to a surface of a patient;

measuring electromyographic signals produced by said electrodes;

analyzing said electromyographic signals

determining potential vector characteristics of said electromyographic signals to identify a direction of propagation of uterine electrical activity; and

characterizing uterine activity of said patient based on said potential vector characteristics.

19. The method of claim 18, wherein said analyzing step further comprises determining a uterine potential vector indicative of a obstetrical diagnosis.

20. The method of claim 19, wherein said diagnosis is of pre-term or term uterine activity.

21. A method of analyzing surface electromyographic data to characterize uterine activity, comprising:

applying action potential measuring electrodes to a surface of a patient;

measuring electromyographic signals produced by said electrodes;

analyzing said electromyographic signals;

integrating energy corresponding to bursts of action potentials within said electromyographic signals to determine an approximate total energy of said bursts of action potentials, and

characterizing uterine activity of said patient based on said approximate total energy.

22. The method of claim 21, wherein said analyzing step further comprises utilizing said approximate total energy and an approximate time for said bursts of action potentials to determine an approximate energy per unit of time, and wherein said characterizing step further comprises characterizing uterine activity of said patient based on said approximate energy per unit of time.

23. An apparatus for recording and analyzing uterine electrical activity from the abdominal surface, comprising:

at least one action potential measuring electrode applicable to a surface of a patient under analysis;

an analog-to-digital converter, connected to said at least one electrode, for converting electromyographic signals produced by said electrode into digitized data indicative of said electromyographic signals;

a memory for storing said digitized signals; and

a programmed computer for analyzing frequency components of said stored digitized electromyographic signals, and for providing an indication of uterine electrical activity of said patient under analysis as a function of said stored digitized signals.

24. The apparatus of claim 23, wherein said programmed computer is further for isolating a fast wave component (FW) within said stored digitized electromyographic signals, for determining a low-frequency (FW_L) domain, including low-frequency components within said fast wave component (FW), and for determining a high-frequency (FW_H) domain, including high-frequency components within said fast wave component (FW).

25. The apparatus of claim 24, wherein said programmed computer is further for determining a relationship between said low-frequency (FW_L) domain and said high-frequency (FW_H) domain indicative of an obstetrical diagnosis.

26. The apparatus of claim 23, wherein said programmed computer is further for determining power density spectral characteristics of said frequency components of said electromyographic signals.

27. The apparatus of claim 23, wherein said programmed computer is further for creating a power density spectrum curve, for integrating said power density spectrum curved to determine an approximate total low energy for said low-frequency (FW_L) domain and an approximate total high energy for said high-frequency (FW_H) domain, and for determining a relationship between said approximate total low-energy and said approximate total high-energy indicative of an obstetrical diagnosis.

28. An apparatus for recording and analyzing uterine electrical activity from the abdominal surface, comprising:

a plurality of action potential measuring electrodes applicable to a surface of a patient under analysis;

an analog-to-digital converter, connected to said plurality of electrodes, for converting electromyographic signals produced by said electrodes into digitized data indicative of said electromyographic signals;

a memory for storing said digitized signals; and

a programmed computer for analyzing said stored digitized electromyographic signals, for determining potential vector characteristics of said electromyographic signals to identify a direction of propagation of uterine electrical activity, and for providing an indication of uterine electrical activity of said patient under analysis as a function of said potential vector characteristics.

29. A remote uterine monitoring system for analyzing surface electromyographic data to characterize uterine activity, comprising:

a remote uterine monitor including;

at least one action potential measuring electrode applicable to a surface of a patient under analysis; and

a remote analog-to-digital converter, connected to said at least one electrode, for converting electromyographic signals produced by said electrode into digitized data indicative of said electromyographic signals; and

a central programmed computer in communication with said remote uterine monitor for analyzing said stored digitized electromyographic signals, and for providing an indication of uterine electrical activity of said patient under analysis as a function of said stored digitized signals.

30. The remote uterine monitoring system of claim 29, wherein said remote uterine monitor and said central programmed computer communicate on-line through a telephone line.

31. The remote uterine monitoring system of claim 29, further comprising a remote storage device for recording said digitized electromyographic signal data, and wherein said central programmed computer communicates with said remote uterine monitor off-line utilizing said remote storage device.