Apparatus and method for the diagnosis of true labor

• US 6,134,466 A
• Filed: 07/27/1998
• Issued: 10/17/2000
• Est. Priority Date: 01/16/1996
• Status: Expired due to Fees

• Current Assignee: Hygeia Biomedical Research Incorporated
• Original Assignee: Hygeia Biomedical Research Incorporated
• Inventors: Rosenberg, Ethan
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US09/123,377
• Time in Patent Office: 813 Days
• Field of Search: 600/551, 600/587, 600/588, 600/595, 600/596
• US Class Current: 600/546
• CPC Class Codes: A61B 5/2415 Measuring direct current [DC] or slowly varying biopotentials
• CPC Class Codes: A61B 5/252 by suction
• 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: A61B 5/7257 using Fourier transforms

Abstract

Disclosed are systems and methods for detecting an onset of true labor in a pregnant mammal. In accordance with a method of this invention the following steps are executed: (a) detected electrical signals from a succession of muscular contractions associated with labor; (b) determining an average frequency of the electrical signals for each contraction; (c) determining a discriminant (δ) from the determined average frequency for each contraction so as to provide a set of discriminants, individual ones of the set of discriminants being associated with an individual one of the contractions; and (d) indicating a beginning of true labor when a slope of at least two discriminants of the set of discriminants exceeds a first threshold value and when a magnitude of a last determined discriminant exceeds a second threshold value. The onset of true labor can also be indicated when a value of a critical determinant exceeds a threshold value, the value of the critical determinant being obtained from a combination of the slope of at least two discriminants of the set of discriminants and a magnitude of a last determined discriminant.

Claims

1. A method for detecting an onset of true labor in a pregnant mammal, comprising the steps of:

detecting electrical signals from a succession of muscular contractions associated with labor;

determining an average frequency of the electrical signals occurring within a burst of electrical signals associated with a contraction;

determining a discriminant (δ

) from the determined average frequency for a plurality of contractions so as to provide a set of discriminants, individual ones of the set of discriminants being associated with an individual one of the contractions; and

indicating a beginning of true labor when a slope of at least two discriminants of the set of discriminants exceeds a first threshold value and when a magnitude of a last determined discriminant exceeds a second threshold value.

2. A method as '"'"'set forth in claim 1, wherein the step of detecting includes the steps of digitizing the electrical signals, and wherein the step of determining an average frequency includes a step of performing a discrete Fourier transform calculation on the digitized electrical signals.

3. A method as set forth in claim 1, wherein the step of detecting includes a step of detecting a time (t1) that each contraction begins and a time (t2) that each contraction terminates.

4. A method as set forth in claim 1, wherein the step of determining a discriminant (δ

) determines the discriminant in accordance with the expression;

space="preserve" listing-type="equation">δ

=κ

f.sub.avg -Λ

where the constants κ and

Λ

are selected so that δ

has a first value for false labor contractions, and a second value for true labor contractions.

5. A method as set forth in claim 1, and further comprising the steps of:

digitizing the detected electrical signals; and

storing the digitized electrical signals; and

wherein the step of indicating includes a further step of;

transmitting at least the stored, digitized electrical signals to a remote location.

6. A method as set forth in claim 1, wherein the step of detecting includes the steps of digitizing the electrical signals and filtering the digitized electrical signals, and further comprising a step of displaying the filtered digitized electrical signals.

7. A method as set forth in claim 1, and further comprising a step of displaying at least one determined discriminant.

8. A method as set forth in claim 1, wherein the step of indicating includes a step of generating at least one of a visual and an aural indicator.

9. A system for detecting an onset of true labor in a pregnant mammal, comprising:

means for detecting electrical signals from a succession of muscular contractions associated with labor;

means for determining an average frequency of the electrical signals occurring within a burst of electrical signals associated with a contraction;

means for determining a discriminant (δ

) from the determined average frequency for each contraction so as to provide a set of discriminants, individual ones of the set of discriminants being associated with an individual one of the contractions; and

means for indicating a beginning of true labor when a slope of at least two discriminants of the set of discriminants exceeds a first threshold value and when a magnitude of a last determined discriminant exceeds a second threshold value.

10. A system as set forth in claim 9, wherein said detecting means includes means for digitizing the electrical signals and means for filtering the digitized electrical signals, and wherein said means for determining an average frequency includes means for performing a discrete Fourier transform calculation on the digitized electrical signals.

11. A system as set forth in claim 9, wherein said means for detecting includes an envelope detector for detecting a time (t1) that each contraction begins and a time (t2) that each contraction terminates.

12. A system as set forth in claim 9, wherein said means for determining a discriminant determines the discriminant in accordance with the expression:

space="preserve" listing-type="equation">δ

=κ

f.sub.avg -Λ

where the constants κ and

Λ

are selected so that δ

has a first value for false labor contractions, and a second value for true labor contractions.

13. A system as set forth in claim 9, and further comprising:

means for digitizing the detected electrical signals; and

means for storing the digitized electrical signals; and

wherein said means for indicating is further comprised of means for transmitting at least the stored, digitized electrical signals to a remote location.

14. A system as set forth in claim 13, wherein said system is adapted to be carried by the pregnant mammal, and further comprising, at the remote location, a practitioner'"'"'s console comprising:

means for receiving and storing the transmitted digitized electrical signals; and

means for processing the received and stored digitized electrical signals.

15. A system as set forth in claim 14, wherein said processing means is comprised of:

second means for determining an average frequency of the electrical signals for each contraction;

second means for determining a discriminant (δ

) from the determined average frequency for each contraction so as to provide a second set of discriminants, individual ones of the second set of discriminants being associated with an individual one of the contractions; and

second means for indicating a beginning of true labor when a slope of at least two discriminants of the second set of discriminants exceeds a first threshold value and when a magnitude of a last determined discriminant exceeds a second threshold value.

16. A system as set forth in claim 9, wherein said detecting means includes means for digitizing the electrical signals and means for filtering the digitized electrical signals, and further comprising means for displaying the filtered digitized electrical signals.

17. A system as set forth in claim 9, and further comprising display means having an input coupled to an output of said determining means for displaying at least one determined discriminant.

18. A system as set forth in claim 9, wherein said indicating means includes means for generating at least one of a visual and an aural indicator.

19. A system as set forth in claim 9, wherein said detecting means includes a set of electrodes that are coupled to the pregnant mammal.

20. A system as set forth in claim 9, wherein said detecting means includes a set of electrodes that are capacitively coupled to the pregnant mammal.

21. A method for detecting an onset of true labor in a pregnant mammal, comprising the steps of:

detecting electrical signals from a succession of smooth muscle contractions associated with labor;

filtering the electrical signals and determining an average frequency (f_avg) of the electrical signals occurring within a burst of electrical signals associated with a contraction;

determining a discriminant (δ

) from the determined average frequency for a plurality of contractions so as to provide a set of discriminants, individual ones of the set of discriminants being associated with an individual one of the contractions, the discriminant (δ

) being determined in accordance with the expression;

space="preserve" listing-type="equation">δ

=κ

f.sub.avg -Λ

where the constants κ and

Λ

are selected so that δ

has a first sign for false labor contractions and a second sign for true labor contractions; and

indicating a beginning of true labor when a slope of at least two discriminants of the set of discriminants exceeds a first threshold value and when a magnitude of a last determined discriminant exceeds a second threshold value.

22. A method as in claim 21, wherein a frequency range of interest is from about 0.1 Hz to about 5.0 Hz, and wherein an onset of true labor is indicated when the average frequency exceeds the frequency range associated with Braxton-Hicks activity.

23. A method as set forth in claim 21, wherein the step of detecting includes the steps of digitizing the electrical signals, and wherein the step of determining an average frequency includes a step of performing a discrete Fourier transform calculation on the digitized electrical signals.

24. A method as set forth in claim 21, wherein the steps of determining and indicating occur locally.

25. A method as set forth in claim 21, wherein at least one of the steps of determining and indicating occur at a remote location, and further comprising the step of transmitting data to the remote location over a telecommunications link.

26. A method as set forth in claim 25, wherein a practitioner'"'"'s console is located at the remote location.

27. A method as in claim 21, and further comprising a step of storing data that represents the detected electrical signals.

28. A method as in claim 27, and further comprising a step of transmitting the stored data to a remote location for at least one of processing the data to determine the discriminant or storage of the data.

29. A method for detecting an onset of true labor in a pregnant mammal, comprising the steps of:

detecting electrical signals from a succession of muscular contractions associated with labor;

determining an average frequency of the electrical signals occurring within a burst of electrical signals associated with a contraction;

determining a discriminant (δ

) from the determined average frequency for a plurality of contractions so as to provide a set of discriminants, individual ones of the set of discriminants being associated with an individual one of the contractions; and

indicating a beginning of true labor when a value of a critical determinant exceeds a threshold value, the value of the critical determinant being obtained from a combination of the slope of at least two discriminants of the set of discriminants and a magnitude of a last determined discriminant.

30. A method as set forth in claim 29, wherein the step of detecting includes the steps of digitizing the electrical signals, and wherein the step of determining an average frequency includes a step of performing a discrete Fourier transform calculation on the digitized electrical signals.

31. A method as set forth in claim 29, wherein the step of detecting includes a step of detecting a time (t1) that each contraction begins and a time (t2) that each contraction terminates.

32. A method as set forth in claim 29, wherein the step of determining a discriminant (δ

) determines the discriminant in accordance with the expression;

space="preserve" listing-type="equation">δ

=κ

f.sub.avg -Λ

where the constants κ and

Λ

are selected so that δ

has a first value for false labor contractions, and a second value for true labor contractions.