Fetal monitoring device and method

• US 8,868,164 B2
• Filed: 03/04/2013
• Issued: 10/21/2014
• Est. Priority Date: 03/04/2013
• Status: Expired due to Fees

• Current Assignee: General Electric Company
• Original Assignee: General Electric Company
• Inventors: Kabakov, Serguei, Falk, Steven M., Fox, Bradley C.
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US13/783,783
• Publication Number:
  US 20140249436A1
• Time in Patent Office: 596 Days
• Field of Search: None
• US Class Current: 600/511
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/288 for foetal cardiography, e.g. scalp electrodes
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/344 Foetal cardiography
• CPC Class Codes: A61B 5/4325 of the uterine cavities, e.g. uterus, fallopian tubes, ovaries
• CPC Class Codes: A61B 5/4362 Assessing foetal parameters
• CPC Class Codes: A61B 5/6806 Gloves
• 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
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61B 6/5211 involving processing of medical diagnostic data
• CPC Class Codes: A61B 8/0866 involving foetal diagnosis; pre-natal or peri-natal diagnosis of the baby
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

A fetal monitoring device includes a piezofilm sheet, a first electrode, and a second electrode. A controller is operably connected to the piezofilm sheet, first electrode, and second electrode and receives a biopotential and a piezofilm signal. The controller derives at least one of a maternal heart rate and a uterine activity for the biopotential and derives at least one of a fetal heart rate and fetal motion detection from the piezofilm signal. The controller derives an index of fetal health and operate an indicator to present the derived index of fetal health.

Claims

1. A fetal monitoring device, comprising:

a piezofilm sheet;

a first electrode;

a second electrode;

a controller operably connected to the piezofilm sheet, the first electrode and the second electrode, the controller receives an acoustic signal from the piezofilm sheet and a biopotential measured between the first electrode and the second electrode and derives at least one of fetal heart rate and fetal motion detection from the acoustic signal and at least one of maternal heart rate and uterine activity from the biopotential and derives an index of fetal health from the at least one of fetal heart rate and fetal motion detection and at least one of maternal heart rate and uterine activity; and

an indicator operable by the controller to present the derived index of fetal health.

2. The fetal monitoring device of claim 1, wherein the fetal monitoring device is incorporated into at least one glove to be worn by a patient.

3. The fetal monitoring device of claim 1, wherein the first electrode and the second electrode are dry electrodes.

4. The fetal monitoring device of claim 1, wherein the controller operates the piezofilm sheet as a speaker to generate a fetal acoustic stimulation signal.

5. The fetal monitoring device of claim 1, wherein the controller derives both the fetal heart rate and the fetal motion detection from the acoustic signal and derives both the maternal heart rate and the uterine activity from the biopotential and calculates the index of fetal health from the fetal heart rate, fetal motion detection, maternal heart rate, and the uterine activity.

6. The fetal monitoring device of claim 5, wherein the calculated index of fetal health is an alert severity, the indicator is at least one LED, and the indicator presents an indication of the alert severity.

7. The fetal monitoring device of claim 5, further comprising an accelerometer that produces an acceleration signal, wherein the controller receives the acceleration signal and removes breathing and motion artifacts from the biopotential and motion artifacts from the acoustic signal based upon the acceleration signal.

8. The fetal monitoring device of claim 5, further comprising a microphone that acquires an ambient sound signal, wherein the controller receives the ambient sound signal and removes external sound artifacts from the acoustic signal based upon the ambient sound signal.

9. The fetal monitoring device of claim 5, wherein the controller removes abdominal pulse artifacts from the piezofilm signal based upon the derived maternal heart rate, and selects a pass band for the piezofilm signal based upon the derived uterine activity before the fetal heart rate is derived from the piezofilm signal.

10. The fetal monitoring device of claim 1, further comprising a wireless transmitter connected to the controller, and the wireless transmitter broadcasts the fetal heart rate, fetal motion detection, maternal heart rate, the uterine activity, and the index of fetal health.

11. A fetal monitoring device, comprising:

at least one glove configured to be worn by a patient, the glove having a forehand side, a backhand side, a thumb region, and at least one finger region;

a piezofilm sheet secured to an exterior of the forehand side of the at least one glove;

a first electrode secured to the forehand side of the thumb region;

a second electrode secured to the forehand side of at least one finger region;

a controller electrically connected to the piezofilm, first electrode, and the second electrode, the controller receives a piezofilm signal from the piezofilm sheet and a biopotential measured between the first electrode and the second electrode and derives a fetal heart rate and a fetal motion detection from the piezofilm signal and derives a maternal heart rate and a uterine activity from the biopotential and derives an index of fetal health from the fetal heart rate, the fetal motion detection, the maternal heart rate, and the uterine activity; and

an indicator operable by the controller to present the index of fetal health.

12. The fetal monitoring device of claim 11, wherein the indicator is an LED device operable to produce at least three visual indications of different levels of the index of fetal health.

13. The fetal monitoring device of claim 12, wherein the controller and the indicator are incorporated into the backhand side of the at least one glove.

14. The fetal monitoring device of claim 13, further comprising a wireless transmitter connected to the controller, and the wireless transmitter broadcasts the fetal heart rate, fetal motion detection, maternal heart rate, the uterine activity, and the index of fetal health.

15. The fetal monitoring device of claim 11, wherein the controller is operable to operate the piezofilm in a first mode wherein the piezofilm collects acoustical data as the piezofilm signal and operate the piezofilm in a second mode wherein the piezofilm produces a fetal acoustic stimulation signal.

16. A method of monitoring the health of a fetus, the method comprising:

providing a mother with a wearable garment that comprises a piezofilm sheet, a first electrode, a second electrode, and a controller;

receiving at the controller a biopotential between the first electrode and the second electrode;

receiving at the controller an acoustic signal from the piezofilm;

deriving with the controller at least one of fetal heart rate and fetal motion detection from the received acoustic signal,

deriving with the controller at least one of maternal heart rate and uterine activity from the received biopotential;

deriving an index of fetal health from the derived at least one of fetal heart rate and fetal motion detection and at least one of maternal heart rate and uterine activity;

visually presenting the index of fetal health.

17. The method of claim 16, further comprising:

operating the piezofilm with the controller to produce a fetal acoustic stimulation signal;

then operating the piezofilm with the controller to acquire the acoustic signal from the piezofilm.

18. The method of claim 16, wherein the wearable garment is at least one glove.

19. The method of claim 16, wherein the index of fetal health is visually presented by illuminating an LED of the wearable garment.

20. The method of claim 16, further comprising:

frequency division multiplexing the fetal heart rate, fetal motion detection, maternal heart rate, and uterine activity;

frequency modulating each of the fetal heart rate, fetal motion detection, maternal heart rate, and uterine activity at a different carrier frequency;

wireless transmitting the modulated and multiplexed fetal heart rate, fetal motion detection, maternal heart rate, and uterine activity with a wireless transmitter of the wearable garment to a monitoring device;

receiving the fetal heart rate, fetal motion detection, maternal heart rate, and uterine activity at the monitoring device;

demodulating the modulated fetal heart rate, fetal motion detection, maternal heart rate, and uterine activity;

visually presenting the fetal heart rate, fetal motion detection, maternal heart rate, and uterine activity at the monitoring device.