Apparatus and methods for the diagnosis of labor

• US 5,483,970 A
• Filed: 02/08/1994
• Issued: 01/16/1996
• 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:
  US08/193,284
• Time in Patent Office: 707 Days
• Field of Search: 128/733, 128/775, 128/778, 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. A monitoring system for use with a pregnant mammal, comprising:

means for obtaining electrical signals from a plurality of superficial abdominal locations of a pregnant mammal, the electrical signals resulting from muscular activity- associated with labor;

means, responsive to the electrical signals obtained from the plurality of superficial abdominal locations, for determining a uterine muscle contraction vector, the uterine muscle contraction vector having a propagation rate component and a propagation direction component with respect to at least a first superficial abdominal location, a second superficial abdominal location, and a third superficial abdominal location; and

means for providing a visual representation of the determined uterine muscle contraction vector.

2. A monitoring system as set forth in claim 1, and further comprising:

electrode interface means having a plurality of inputs for coupling to a plurality of electrodes that are affixed, during use, to the superficial abdominal locations of the pregnant mammal, the plurality of electrodes generating said electrical signals in response to a uterine muscle contraction, said electrode interface means having a plurality of outputs;

input means for inputting a position of individual ones of said plurality of electrodes, the position being relative to a predetermined coordinate system that is referenced to a superficial abdominal region of the pregnant mammal; and

means for storing said inputted electrode positions.

3. A monitoring system as set forth in claim 2 and further comprising:

a plurality of envelope detector means, individual ones of which have an input coupled to one of said outputs of said electrode interface means, each of said envelope detector means having an output; and

a plurality of electrical activity detector means, individual ones of which have an input coupled to one of said outputs of said plurality of envelope detector means, each of said electrical activity detector means having an output.

4. A monitoring system as set forth in claim 3 and further comprising:

a plurality of vector determination means, individual ones of which have a first input coupled to an output of one of said electrical activity detector means and second input coupled to an output of a second one of said electrical activity detector means, each of said vector determination means having an output for outputting a signal that is indicative of a uterine muscle contraction that propagates between two electrodes.

5. A monitoring system as set forth in claim 4 wherein said signal output from each of said plurality of vector determination means is coupled to an input of said means for providing a visual representation.

6. A monitoring system as set forth in claim 4 and further comprising a vector change determination means having a first input coupled to said output of one of said plurality of vector determination means and a second input coupled to said output of another one of said vector determination means, said vector change determination means having an output for indicating a change in a rate of propagation or in a direction of propagation of one uterine muscle contraction vector with respect to another uterine muscle contraction vector.

7. A Monitoring system as set forth in claim 4 wherein said signal output from each of said plurality of vector determination means is coupled to an input of said means for providing a visual representation.

8. A monitoring system as set forth in claim 3 and further comprising:

labor onset determination means having inputs coupled to said outputs of said electrical activity detector means and, responsive to said outputs, for generating a signal indicating a probable onset of labor.

9. A monitoring system as set forth in claim 3 wherein said signal output from each of said plurality of envelope detector means is coupled to an input of said means for providing a visual representation.

10. A monitoring system as set forth in claim 1 and further comprising:

analog to digital conversion means, having an input coupled to an output-of said obtaining means, for converting the obtained electrical signals to a digital representation thereof; and

memory means, having an input coupled to an output of said analog to digital conversion means, for storing the digital representation.

11. A monitoring system as set forth in claim 10 and further comprising:

communication means having an input coupled to an output of said memory means and an output coupled to an a communication link for transmitting the stored digital representation to a remote location over the communication link.

12. A monitoring system as set forth in claim 11 wherein said means for determining a uterine muscle contraction vector and said means for providing a visual representation of the determined uterine muscle contraction vector are located at the remote location;

and wherein said means for determining a uterine contraction vector has an input coupled to the communication link for receiving the stored digital representation therefrom for determining the uterine muscle contraction vector in accordance with the received digital representation.

13. A monitoring System as set forth in claim 11 and further comprising:

means, responsive to the detected electrical signals, for generating a signal indicating an onset of true labor; and

means, responsive to the generated signal, for transmitting the stored digital representation to the communication link.

14. A monitoring system as set forth in claim 1 and further comprising:

means for detecting electrical activity associated with an arrival of a uterine muscle contraction at a position associated With a first stored electrode position;

means, responsive to the stored electrode positions, for identifying at least one other electrode;

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

means for 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 resulting from the arrival of the propagating uterine muscle contraction at the at least one other electrode;

wherein

said uterine muscle contraction vector determining means determines the propagation rate component and the direction component in response to the arrival of the propagating uterine muscle contraction at the at least one other electrode, wherein the propagation rate component is a function of a distance between the first electrode and the second electrode, and is also a function of a transit time of the propagating uterine muscle contraction between the first and second electrodes, and wherein the propagation direction component is indicative of the direction of a line between the first electrode and the second electrode.

15. A monitoring system as set forth in claim 1 and further comprising:

means, responsive to the detected electrical signals, for determining an extent of cervical dilation.

16. A monitoring system as set forth in claim 15 wherein said interface means includes means for providing a DC interface with at least one electrode., and wherein said means for determining an extent of cervical dilation operates in response to electrical signals obtained from said at least one electrode.

17. A monitoring system for use with a pregnant mammal, comprising:

means for periodically obtaining electrical signals from a plurality of superficial abdominal regions of a pregnant mammal, the electrical signals resulting from muscular activity associated with labor;

means, responsive, to the obtained electrical signals, for determining if a contraction of the uterine muscle is in progress; and

means, responsive to said determining means determining that a contraction is not in progress, for processing the obtained electrical signals, and for outputting an indication of an extent of cervical dilation.

18. A monitoring system as set forth in claim 17 wherein said obtaining means is comprised of means for providing a DC interface with at least one electrode, and wherein said means for determining an extent of cervical dilation operates in response to electrical signals obtained from said at least one electrode.

19. A monitoring system as set forth in claim 17 and further comprising:

analog to digital conversion means, having an input coupled to an output of said obtaining means, for converting the obtained electrical signals to a digital representation thereof;

memory means, having an input coupled to an output of said analog to digital conversion means, for storing the digital representation; and

communication means having an input coupled to an output of said memory means, and an output coupled to a communication link, for transmitting the stored digital representation to a remote location over the communication link.

20. A monitoring system for use with a pregnant mammal, comprising:

means for obtaining electrical signals from a plurality of superficial abdominal locations of a pregnant mammal, the electrical signals resulting from muscular activity associated with labor;

first memory means coupled to an output of said obtaining means for storing a digital representation of said electrical signals;

analyzing means having an input coupled to an output of said first memory means and responsive to the stored representation therein for determining from said stored representation at least one characteristic of the labor; and

means, responsive to said analyzing means determining said at least one characteristic of the labor, for transmitting at least a portion of said stored digital representation to a second memory means for storage in said second memory means.

21. A monitoring system as set forth in claim 20 wherein said at least one characteristic includes at least one of a uterine muscle contraction vector and an amount of dilation of the cervix.