Method and device for contraction monitoring

• US 10,456,074 B2
• Filed: 10/29/2015
• Issued: 10/29/2019
• Est. Priority Date: 10/29/2014
• Status: Active Grant

• Current Assignee: Bloom Technologies NV
• Original Assignee: Bloom Technologies NV
• Inventors: Penders, Julien, Altini, Marco, Dy, Eric, Berset, Torfinn, Rooijakkers, Michiel
• Primary Examiner(s): Weare, Meredith
• Application Number:
  US15/523,072
• Publication Number:
  US 20180296156A1
• Time in Patent Office: 1,461 Days
• CPC Class Codes: A61B 2503/02 Foetus
• CPC Class Codes: A61B 5/02411 of foetuses
• CPC Class Codes: A61B 5/1107 Measuring contraction of parts of the body, e.g. organ, muscle apparatus for measuring work or force in general G01L
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/165 Evaluating the state of mind, e.g. depression, anxiety
• CPC Class Codes: A61B 5/288 for foetal cardiography, e.g. scalp electrodes
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/333 Recording apparatus specially adapted therefor
• CPC Class Codes: A61B 5/344 Foetal cardiography
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4356 Assessing uterine contractions A61B5/033 takes precedence
• CPC Class Codes: A61B 5/4362 Assessing foetal parameters
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/721 using a separate sensor to detect motion or using motion information derived from signals other than the physiological signal to be measured

Abstract

Described herein are systems and methods for contraction monitoring. For example, a system for contraction monitoring includes an electrode patch including at least two electrodes, and a sensor module configured to be connected to the electrode patch. In some embodiments, the sensor module includes a signal acquisition module, a signal processing module, a power management module, a sensor control module, and a memory module and/or a data transmission module. In some embodiments, a method for contraction monitoring includes measuring, using the signal acquisition module, bio-potential signals by providing at least two electrodes on the abdomen of a pregnant woman. In some embodiments, a method for contraction monitoring includes processing, using the signal processing module, the bio-potential signal to extract electrohysterogram signals, maternal electrocardiogram signals and fetus electrocardiogram signals, and processing, using the signal processing module, the individual signals to extract uterine contraction.

Claims

1. A contraction monitoring system comprising:

an electrode patch comprising at least two electrodes, including a first measurement electrode and a reference electrode, wherein the electrode patch is positionable on an abdomen of a pregnant woman; and

a sensor module configured to be connected to the electrode patch, wherein the sensor module is configured to perform a method comprising;

measuring a biopotential signal with the at least two electrodes,

acquiring inertial sensing data with an inertial sensing module,

automatically identifying the inertial sensing data that comprises one or more motion artifact signals resulting from the overall movement of the pregnant woman, movements of the abdomen induced by fetal movement, and local movement of the sensor module,

inputting the inertial sensing data and out of band energy for the biopotential signal into an artifact filter, wherein the input comprises adapting a threshold over time dependent on the out of band energy,

dynamically adjusting the threshold by calculating a moving baseline energy such that the moving baseline energy adapts with time to follow changes in the inertial sensing data or the out of band energy signal, and dynamically changing the threshold based on the moving baseline energy,

dynamically adjusting the artifact filter by calculating a sensor motion energy from the inertial sensing data, establishing a set minimum level for the sensor motion energy, and lowering the threshold in proportion to the amount by which the sensor motion energy exceeds the minimum level,

filtering or excluding, with the artifact filter, the one or more motion artifact signals from the biopotential signal,

processing the filtered biopotential signal, with a signal processing module, to extract one or more electrohysterogram signals, and

processing the one or more electrohysterogram signals, with the signal processing module, to extract one or more uterine contraction signals.

2. The system of claim 1, wherein the method performed by the sensor module further comprises:

processing the filtered biopotential signal to extract one or more of;

maternal electrocardiogram signals (mECG) and fetus electrocardiogram signals (fECG).

3. The system of claim 2, wherein the method performed by the sensor module further comprises:

processing the mECG signals to extract a maternal heart rate (mHR) and maternal heart rate variability (mHRV);

processing mHR and mHRV to extract a maternal stress level; and

correlating the one or more uterine contraction signals with the maternal stress level.

4. The system of claim 3, wherein the method performed by the sensor module further comprises:

providing feedback to a user.

5. The system of claim 2, wherein the method performed by the sensor module further comprises:

processing the fECG signals to extract a fetal heart rate (fHR) and fetal heart rate variability (fHRV); and

correlating the one or more uterine contraction signals with one or more of;

the fHR and the fHRV.

6. The system of claim 2, wherein the method performed by the sensor module further comprises:

extracting one or more of;

a position, a movement, and an orientation of a fetus from the fECG; and

measuring a fetal activity from one or more of;

the position, the movement, and the orientation of the fetus.

7. The system of claim 1, wherein the method performed by the sensor module further comprises:

isolating from the one or more electrohysterogram signals a first part of the one or more electrohysterogram signals that is related to an electrical activity of a uterus; and

separating the electrical activity of the uterus from a second part of the one or more electrohysterogram signals that is related to other physiological phenomena, noise, or artifacts.

8. The system of claim 1, wherein the method performed by the sensor module further comprises:

processing the electrohysterogram signals to extract one or more electrohysterogram markers; and

classifying the biopotential signal into contraction types based on the one or more electrohysterogram markers.

9. The system of claim 8, wherein the one or more electrohysterogram markers comprise:

a statistical feature selected from the group consisting of;

an average, a mean, a percentile, a standard deviation, a kurtosis, and a combination thereof;

a power spectrum feature selected from the group consisting of;

a total power in a bandwidth, a peak power, a mean power, an average power, a power in certain frequency bands, an entropy feature, and a combination thereof;

or

a spatial propagation feature selected from the group consisting of;

a laplacian, a gradient, a higher order propagation feature to indicate a rate, a pattern, and a spatial distribution of a firing of one or more uterine contractile cells, and a combination thereof.

10. The system of claim 1, wherein the method performed by the sensor module further comprises:

analyzing the one or more uterine contraction signals to compute uterine contraction statistics.

11. The system of claim 10, wherein the sensor module further comprises an inertial sensing module or is configured to interact with an activity sensor provided by another device, and wherein the method performed by the sensor module further comprises:

measuring a maternal activity; and

correlating the maternal activity with the one or more uterine contraction signals, the uterine contraction statistics, or a combination thereof.

12. The system of claim 10, wherein the method performed by the sensor module further comprises:

correlating the one or more uterine contraction signals, the uterine contraction statistics, or combination thereof with a fetal activity.

13. The system of claim 1, wherein the electrode patch further comprises a bias electrode and a second measurement electrode, wherein the first and second measurement electrodes are located on two extremities of the electrode patch, and wherein the reference electrode is located substantially in a middle region of the electrode patch.

14. The system of claim 13, wherein the electrode patch further comprises a third measurement electrode, wherein the first and second measurement electrode and the reference electrode are positioned substantially on a line, and wherein the third measurement electrode is positioned below the reference electrode substantially perpendicular to the line.

15. The system of claim 1, further comprising a user personal device configured to perform one or more functions performed by the sensor module.

16. The system of claim 15, wherein the one or more functions carried out by the user personal device further comprise:

using context information received by the user personal device to improve an accuracy and a reliability of measuring one or more of;

a uterine contraction activity estimation, a maternal activity estimation, a maternal stress estimation, a fHR estimation, a fHRV estimation, a fetal movement estimation, and fetal position estimation; and

providing feedback to a user to promote a healthy lifestyle and reduce one or more risks related to pregnancy.

17. The system of claim 1, wherein filtering or excluding the one or more motion artifact signals from the biopotential signal slowly returns the threshold to an original value after sharp motions have subsided.

18. The systems of claim 1, wherein the out of band energy is outside of the frequency range of 0.2 Hz and 0.9 Hz.