Fetal ECG monitoring

• US 7,949,389 B2
• Filed: 04/15/2009
• Issued: 05/24/2011
• Est. Priority Date: 04/15/2008
• Status: Active Grant

• Current Assignee: E-Trolz, Inc., Tufts Medical Center Incorporated (Healthcare Realty Trust, Inc.), Massachusetts Institute of Technology
• Original Assignee: E-Trolz, Inc., Tufts Medical Center Incorporated (Healthcare Realty Trust, Inc.), Massachusetts Institute of Technology
• Inventors: Ward, Jay, Clifford, Gari D., Wolfberg, Adam J.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): WU, TONG E
• Application Number:
  US12/424,046
• Publication Number:
  US 20090259133A1
• Time in Patent Office: 769 Days
• Field of Search: 600/304, 600/376, 600/388, 600/390, 600/393, 600/483, 600/509, 600/511, 600/516, 600/517, 607/25, 607/26
• US Class Current: 600/511
• CPC Class Codes: A61B 5/02411 of foetuses
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/344 Foetal cardiography
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/4362 Assessing foetal parameters

Abstract

A method for fetal monitoring includes acquiring electrical signals from a set of electrodes, for example, a set of surface electrodes applied to a maternal abdominal region. The electrical signals are analyzed, including by performing a morphological analysis of fetal electrocardiogram signals. A clinical indicator is then determined from a result of performing the morphological analysis.

Claims

1. A method for fetal monitoring comprising:

acquiring electrical signals from a plurality of electrodes, including a plurality of electrodes applied to a maternal abdominal region;

analyzing the electrical signals, including performing a morphological analysis of fetal electrocardiogram signals;

determining a clinical indicator of a pathologic condition from a result of performing the morphological analysis.

2. The method of claim 1 wherein performing the morphological analysis includes determining a quantitative measure of morphological variation.

3. The method of claim 2 wherein determining the quantitative measure of morphological variation includes characterizing segments of signals determined from the acquired electrical signals according to a group of classes, and determining a measure of variation in sequences of segment classifications.

4. The method of claim 2 wherein the quantitative measure of morphological variation includes an entropy of a sequence of segment classifications.

5. The method of claim 1 wherein determining a clinical indicator includes determining an indicator of a fetal condition.

6. The method of claim 1 wherein determining a clinical indicator includes determining an indicator of an inflammation condition.

7. The method of claim 1 wherein determining a clinical indicator includes determining an indicator of at least one of chorioamnionitis, preeclampsia, inflammation, and infection.

8. A fetal monitoring system comprising:

a data acquisition system for acquiring surface signals including signals representing surface measurements of cardiac activity;

a signal analyzer coupled to the data acquisition system, configured to analyze the acquired surface signals to generate an output having at least a clinical indicator characterizing a pathologic condition, the signal analyzer including;

a signal processor for extracting fetal electrocardiogram signals from the acquired surface signals; and

a clinical condition detector configured to perform a morphological analysis of the extracted fetal electrocardiogram signals, and based on a result of the morphological analysis, determining the clinical indicator; and

an output system for presenting a representation of the clinical indicator.

9. The fetal monitoring system of claim 8, wherein the data acquisition system includes an electrode array having at least a plurality of electrodes attachable to a maternal abdominal region.

10. The fetal monitoring system of claim 9, wherein the electrode array further includes a second plurality of electrodes attachable to a maternal lumbar region.

11. The fetal monitoring system claim 10, wherein the electrode array further includes a third plurality of electrodes attachable to a maternal side region.

12. The fetal monitoring system of claim 11, wherein the pluralities of electrodes are positioned in a pre-determined arrangement on a garment.

13. The fetal monitoring system of claim 8, wherein the output system includes a display unit for generating a visual representation of the output of the signal analyzer.

14. The fetal monitoring system of claim 13, wherein the display unit includes a computer screen.

15. The fetal monitoring system of claim 13, wherein the display unit includes a handheld device.

16. The fetal monitoring system of claim 15, further comprising a wireless transmitter for transmitting the output of the signal analyzer to the handheld device.

17. The fetal monitoring system of claim 8, wherein the signal analyzer further includes a heart rate detector for determining a fetal heart rate from the acquired surface signals.

18. The fetal monitoring system of claim 17, wherein the output system is further configured for presenting a representation of the fetal heart rate determined by the signal analyzer.

19. The fetal monitoring system of claim 17, wherein the heart rate detector is further configured for determining a degree of irregularity in the fetal heart rate.

20. The fetal monitoring system of claim 8, wherein the clinical condition detector is further configured for determining a measure of morphological variation in the extracted fetal electrocardiogram signals.

21. The fetal monitoring system of claim 20, wherein the measure of morphological variation includes an entropy of a sequence of segment classifications.

22. The fetal monitoring system of claim 8, wherein the clinical indicator determined by the clinical condition detector includes an indicator of a fetal condition.

23. The fetal monitoring system of claim 8, wherein the clinical indicator determined by the clinical condition detector includes an indicator of at least one pathologic condition from the group consisting of chorioamnionitis, preeclampsia, inflammation, infection, hypoxia, hypoxemia, and metabolic acidosis.

24. The fetal monitoring system of claim 8, wherein the output system is further configured for presenting a waveform representation of the fetal electrocardiogram signals.

25. The fetal monitoring system of claim 8, further comprising a signal selection unit coupled to the signal analyzer for selectively rejecting one or more of the acquired signals based on a quality of the acquired surface signals.

26. The system of claim 8 wherein the signal processor for extracting fetal electrocardiogram signals is configured to a) remove noise, b) remove artifacts, c) separate maternal signals, d) determine maternal heart rate, and e) determine fetal heart rate.

27. The system of claim 8 wherein the data acquisition module includes a signal conditioning module for filtering out undesirable noise and amplification.

28. The system of claim 27 wherein the data acquisition module further includes a digitization module for conversion at a sampling rate of 1000 samples per second and a resolution of 16 bits.