Apparatus and method for the diagnosis of labor

• US 5,301,680 A
• Filed: 12/09/1992
• Issued: 04/12/1994
• Est. Priority Date: 12/09/1992
• Status: Expired due to Fees

• Current Assignee: Hygeia Biomedical Research Incorporated
• Original Assignee: Hygeia Biomedical Research Incorporated
• Inventors: Rosenberg, Ethan
• Primary Examiner(s): Sykes, Angela D.
• Application Number:
  US07/988,433
• Time in Patent Office: 489 Days
• Field of Search: 128/775, 128/778, 128/733, 128/903-904
• US Class Current: 600/546
• CPC Class Codes: A61B 5/391 of genito-urinary organs
• CPC Class Codes: A61B 5/4356 Assessing uterine contractions A61B5/033 takes precedence
• CPC Class Codes: Y10S 128/903 Radio telemetry

Abstract

Disclosed are methods and apparatus for the electromyographic detection of electrical fields inherent in muscular activity, for the diagnosis of labor in a pregnant mammal. The apparatus includes a system (10) for determining a periodicity, and for measuring a magnitude and a direction of movement, of the electrical signal in an abdominal region, and for processing the signal to indicate normal and abnormal labor conditions, the onset of true labor, and the extent of cervical dilation. A Labor Onset processor (16e) determines the onset of true labor. A Vector Determination processor (16b) determines a uterine contraction vector having a propagation rate component and a direction component, relative to a plurality of measurement electrodes. The positions of the measurement electrodes are referenced to a coordinate system and are specified to the system through a data entry device (20). A display (18a, 18b) provides a visual or audible indication of labor diagnostic information, the diagnostic information being expressed in a number of formats. The invention also provides for remotely monitoring a pregnant mammal through the use of a communications link (32).

Claims

1. Apparatus for use in diagnosing labor in a pregnant mammal, comprising:

means for detecting electrical fields inherent in muscular activity associated with labor;

means, responsive to the detected electrical fields resulting from a uterine contraction, for determining at each of a plurality of superficial abdominal regions a rate and a direction of movement of muscular activity; and

means for displaying information expressive of the determined rate and direction of muscular activity determined from the plurality of superficial abdominal regions to provide diagnostic information regarding the uterine contraction.

2. Apparatus as set forth in claim 1 and further including means for providing an indication if the rate and the direction of the movement of muscular activity is outside of a predetermined range of rate and direction of movement.

3. Apparatus as set forth in claim 1 wherein said detecting means includes:

means having inputs for coupling to a set of electrodes, the set of electrodes being affixed externally to a pregnant mammal; and

means for processing electrical activity detected by a plurality of the electrodes of the set of electrodes so as to provide an electrical signal, for each of the plurality of electrodes, that is representative of the electrical activity detected by each of the plurality of electrodes.

4. Apparatus as set forth in claim 3 and further including means, responsive to the electrical signal, for indicating at an output thereof an occurrence of an arrival of a uterine contraction at a location that corresponds to a location of an electrode that measures the electrical signal.

5. Apparatus as set forth in claim 4 wherein said indicating means includes means for providing an output signal, the output signal including information for identifying the electrode and information for identifying a time at which a contraction arrived at the electrode.

6. Apparatus as set forth in claim 4 wherein said determining means includes means, having inputs coupled to the output of at least two of said indicating means, for determining and outputting a uterine contraction vector, the uterine contraction vector having a propagation rate component and a direction component.

7. Apparatus as set forth in claim 6 wherein said displaying means displays a representation of the determined uterine contraction vector.

8. Apparatus as set forth in claim 6 and further including means, having inputs coupled to said uterine contraction vector determining means, for comparing successively determined uterine contraction vectors to determine if the propagation rate components of two successively determined uterine contraction vectors differ from one another by more than a predetermined amount.

9. Apparatus as set forth in claim 8 wherein said comparing means includes means for indicating if the propagation rate components of two successively determined uterine contraction vectors differ from one another by more than the predetermined amount.

10. Apparatus as set forth in claim 3 and further comprising means for inputting and for storing information that specifies the positions of electrodes with respect to a coordinate system.

11. Apparatus as set forth in claim 10 wherein the positions of said plurality of electrodes are referenced to a polar coordinate system having an origin, and wherein said means for inputting and for storing, inputs and stores the distance of each of said electrodes from the origin, and the angular displacement of each of said electrodes from a reference axis.

12. Apparatus as set forth in claim 11 wherein the origin is referenced to the umbilicus, and wherein the reference axis is referenced to a line that runs between the umbilicus and the xiphoid.

13. Apparatus as set forth in claim 1 and further including means, responsive to the detected electrical fields, for determining a condition indicative of an onset of labor.

14. Apparatus for use in diagnosing labor in a pregnant mammal, comprising:

means for detecting electrical fields inherent in muscular activity associated with labor;

means, responsive to the detected electrical fields, for determining a rate and a direction of movement of muscular activity;

means for displaying information expressive of the determined rate and direction of muscular activity to provide diagnostic information regarding a uterine contraction; and

means, responsive to the detected electrical fields, for determining and displaying an extent of cervical dilation.

15. Apparatus as set forth in claim 14 wherein said cervical dilation determining means includes means for measuring a magnitude of a DC offset of an electrical signal derived from an electrode that is externally affixed to the pregnant mammal, and wherein said means for displaying an extent of said cervical dilation is responsive to said measured magnitude of the DC offset for displaying same as a representation of the extent of the cervical dilation.

16. Apparatus for use in diagnosing labor in a pregnant mammal, comprising:

means for detecting electrical fields inherent in muscular activity associated with labor; and

means, responsive to the detected electrical fields, for determining and displaying an extent of cervical dilation.

17. Apparatus as set forth in claim 16 wherein said cervical dilation determining means includes means for measuring a magnitude of a DC offset of an electrical signal derived from an electrode that is externally affixed to the pregnant mammal, and wherein said means for displaying an extent of said cervical dilation is responsive to said measured magnitude of the DC offset for displaying same as a representation of the extent of the cervical dilation.

18. Apparatus as set forth in claim 16 and further including:

means, responsive to the detected electrical fields, for determining a rate and a direction of movement of muscular activity; and

means for displaying information expressive of the determined rate and direction of muscular activity to provide diagnostic information regarding a uterine contraction.

19. Apparatus as set forth in claim 18 wherein said rate and direction determining means includes means for determining and displaying a uterine contraction vector, the uterine contraction vector having a propagation rate component and a direction component.

20. Apparatus as set forth in claim 19 and further including means, having inputs coupled to said uterine contraction vector determining means, for comparing successively determined uterine contraction vectors to determine if the propagation rate component of two successively determined uterine contraction vectors differ from one another by more than a predetermined amount, said comparing means including means for indicating if the propagation rate component of two successively determined uterine contraction vectors differ from one another by more than the predetermined amount.

21. A method for use in diagnosing labor in a pregnant mammal, comprising the steps of:

detecting electrical fields inherent in muscular activity associated with labor;

responsive to the detected electrical fields resulting from a uterine contraction,

determining at each of a plurality of superficial abdominal regions a rate and a direction of movement of muscular activity;

and

displaying information expressive of the determined rate and direction of muscular activity to provide diagnostic information regarding the uterine contraction.

22. A method as set forth in claim 21 and further including a step of providing an indication if the rate and the direction of the movement of muscular activity indicates an abnormality.

23. A method as set forth in claim 21 wherein the step of detecting includes the initial steps of:

inputting and storing positional information that specifies the positions of a plurality of electrodes that are externally affixed to the pregnant mammal, the plurality of electrodes being referenced to a predetermined coordinate system.

24. A method as set forth in claim 23 wherein the predetermined coordinate system is a polar coordinate system, and wherein the step of inputting and storing inputs stores a distance of each of the electrodes from the origin, and also inputs and stores an angular displacement of each of the electrodes from a reference axis.

25. A method as set forth in claim 24 wherein the origin is referenced to the umbilicus, and wherein the reference axis is referenced to a line that runs between the umbilicus and the xiphoid.

26. A method as set forth in claim 21 wherein the step of determining the rate and direction of muscular activity determines and displays a uterine contraction vector, the uterine contraction vector having a propagation rate component and a direction component.

27. A method as set forth in claim 26, wherein the step of determining a uterine contraction vector includes the steps of:

detecting electrical activity associated with an arrival of a uterine contraction at a position associated with a first electrode that is externally affixed to the pregnant mammal;

identifying the position of at least one other electrode that is externally affixed to the pregnant mammal;

determining a maximum transit time for a uterine contraction to propagate from the first electrode to the at least one other electrode;

monitoring the at least one other electrode for a period of time at least equal to the determined maximum transit time to detect electrical activity associated with the arrival of the propagating uterine contraction; and

determining the uterine contraction vector having the propagation rate component and the direction component in response to the arrival of the propagating uterine contraction at a second one of the other electrodes, wherein the propagation rate component is a function of the distance between the first electrode and the second electrode, and also a function of the transit time of the propagating uterine

contraction between the first and second electrodes, and wherein the direction component is indicative of the direction of a line between the first electrode and the second electrode.

28. A method as set forth in claim 21 wherein the step of determining the rate and direction of muscular activity determines a uterine contraction vector, and further comprising the steps of:

comparing successively determined uterine contraction vectors to determine if a propagation rate component of two successively determined uterine contraction vectors differ from one another by more than a predetermined amount; and

generating an indication if the propagation rate component of two successively determined uterine contraction vectors differ from one another by more than the predetermined amount.

29. A method as set forth in claim 21 and further including a step of detecting an onset of labor in response to the detected electrical fields.

30. A method as set forth in claim 21 wherein the step of detecting includes a step of transmitting measurements from a plurality of measurement electrodes that are affixed to the pregnant mammal.

31. A method as set forth in claim 30 wherein the step of transmitting includes an initial step of digitizing the measurements prior to transmission.

32. A method for use in diagnosing labor in a pregnant mammal, comprising the steps of:

detecting electrical fields inherent in muscular activity associated with labor;

determining a rate and a direction of movement of muscular activity in response to the detected electrical fields;

displaying information expressive of the determined rate and direction of muscular activity to provide diagnostic information regarding a uterine contraction; and

determining and displaying an extent of cervical dilation, the step of determining the extent of cervical dilation being accomplished in response to the detected electrical fields.

33. A method as set forth in claim 32 wherein the step of determining the extent of cervical dilation includes a step of determining a magnitude of a DC offset of an electrical signal derived from an electrode that is externally affixed to the pregnant mammal, and wherein the step of displaying an extent of the cervical dilation includes a step of displaying the determined magnitude of the DC offset as a representation of the extent of the cervical dilation.

34. Apparatus for use in diagnosing labor in a pregnant mammal comprising:

means for detecting electrical fields inherent in muscular activity associated with labor;

means, responsive to the detected electrical fields resulting from a uterine contraction, for determining at each of a plurality of superficial abdominal regions a rate and direction of movement of the electrical fields; and

means, responsive to the determined rate and direction of movement at each of the plurality of superficial abdominal regions, for providing an indication of an onset of true labor.

35. Apparatus for use in diagnosing labor in a pregnant mammal, comprising:

means for detecting electrical fields inherent in muscular activity associated with labor;

means, responsive to the detected electrical fields resulting from a uterine contraction, for determining at each of a plurality of superficial abdominal regions a rate and direction of movement of the electrical fields; and

means, responsive to the determined rate and direction of movement at each of the plurality of superficial abdominal regions, for distinguishing true labor from false labor.

36. Apparatus for use in diagnosing labor in a pregnant mammal, comprising:

means for detecting electrical fields inherent in uterine muscular activity associated with labor;

means, responsive to the detected electrical fields resulting from a uterine contraction, for determining at each of a plurality of superficial abdominal regions a change in a rate and a direction of movement of the electrical fields; and

means, responsive to the determined change in the rate and direction of movement at each of the plurality of superficial abdominal regions, for providing an indication of a possible occurrence of excessive stress being exerted upon a portion of the uterine muscle.

37. Apparatus for assisting a practitioner in diagnosing labor in a pregnant mammal, comprising:

means for detecting electrical fields inherent in muscular activity associated with labor, said detecting means being operable for detecting electrical fields that propagate between a plurality of superficial abdominal regions;

means for transmitting information over a communications link, the transmitted information including information that is expressive of the detected electrical fields;

means for receiving the transmitted information; and

means, responsive to the received information, for providing diagnostic information concerning the labor of the pregnant mammal, said providing means including,

means, responsive to the detected electrical fields, for determining for each of the plurality of superficial abdominal regions a rate and a direction of movement of muscular activity; and

means for displaying information expressive of the determined rate and direction of muscular activity determined for the plurality of superficial abdominal regions.

38. Apparatus as set forth in claim 37 and further including means, having an input coupled to an output of said detecting means and an output coupled to an input of said transmitting means, for storing the information prior to the transmission thereof.

39. Apparatus as set forth in claim 37 and further including means, having an input coupled to an output of said detecting means, for identifying a probable onset of true labor.

40. Apparatus as set forth in claim 37 and further including:

means, having an input coupled to an output of said detecting means and an output coupled to an input of said transmitting means, for storing the information prior to the transmission thereof; and

means, having an input coupled to an output of said detecting means, for identifying a probable onset of true labor and, responsive to the identification of the probable onset of true labor, for activating said transmitting means to transmit the information stored within said storing means.

41. Apparatus as set forth in claim 37 and further including means, having an input coupled to an output of said receiving means, for storing the received information.

42. Apparatus as set forth in claim 37 wherein the transmitted information is expressive of a labor-associated condition that is selected from the group that includes at least one of (a) a differentiation of true labor from false labor and other pathological conditions, (b) a presence of undue stress on a part of the uterine muscle, (c) an onset of true labor, and (d) an extent of cervical dilation.