Ambulatory non-invasive automatic fetal monitoring system

• US 4,781,200 A
• Filed: 10/04/1985
• Issued: 11/01/1988
• Est. Priority Date: 10/04/1985
• Status: Expired due to Term

• Current Assignee: Baker, Donald A.
• Original Assignee: Baker, Donald A.
• Inventors: Baker, Donald A.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US06/784,663
• Time in Patent Office: 1,124 Days
• Field of Search: 128/661, 128/671, 128/698, 128/775, 128/778, 128/782, 128/706
• US Class Current: 600/483
• CPC Class Codes: A61B 5/02411 of foetuses
• CPC Class Codes: A61B 5/4362 Assessing foetal parameters
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses
• CPC Class Codes: A61B 5/7257 using Fourier transforms
• CPC Class Codes: A61B 7/04 Electric stethoscopes microphones, acoustic transducers therefor H04R

Abstract

Fetal monitors for automatically and continuously monitoring the well-being of a fetus. The preferably ambulatory monitors include one or more fetal cardiac sensors for detecting the fetal heart rate. The sensors can be acoustic, electrocardiographic or bioimpedence types. Interference sensors are included for selectively sensing the principle interference components contained in the fetal cardiac sensor signals. The preferred microprocessor based signal processing system converts the sensor signals into digital format and transforms the signals from time domain into frequency domain and back into time domain after appropriate processing. Adaptive cancellation of interfering signals and other signal enhancing operations are disclosed. Analytical subsystems continuously analyze the fetal heart rate information and information from a fetal movement sensor to perform a fetal non-stress test. Subsystems for other analytical tests are also disclosed. Alarms warn the mother when fetal behavior is outside of preprogrammed acceptable limits of such analytical tests so that remedial action may be initiated. The monitoring system also preferably includes a sensor belt for properly and conveniently wearing the sensors and a control unit containing the signal processing and related components.

Claims

1. An ambulatory, non-invasive, automatic fetal monitoring system for use on a mother to continuously measure and analyze information indicative of the well-being of a fetal living within the mother, comprising:

a sensor garment for wear by the mother about the mother'"'"'s torso;

a plurality of fetal cardiac sensor means mounted on said sensor garment at spaced locations to continuously detect fetal heartbeats when the fetus is in a variety of positions within the mother and provide

electronic fetal cardiac sensor signals at least one of which is indicative of fetal heartbeats with time;

at least one fetal movement sensor means mounted on said sensor garment to continuously detect physical movement of the fetus within the mother and provide at least one electronic fetal movement sensor signal which is indicative of fetal movement;

a computing means connected to receive and analyze said cardiac and movement sensor signals to determine fetal heart rate and including means to perform at least one analysis relating fetal heart rate and detected movement by the fetus;

heart rate indicator means for indicating fetal heart rate; and

means for indicating results of the analysis relating fetal heart rate and detected movement by the fetus.

2. The automatic fetal monitoring system of claim 1 wherein the fetal cardiac sensors are electrocardiographic sensors.

3. The automatic fetal monitoring system of claim 1 wherein the fetal cardiac sensors are acoustical sensors.

4. The automatic fetal monitoring system of claim 1 further comprising adaptive signal cancellation means for adaptively cancelling at least a portion of at least one cardiac sensor signal to increase the strength of signals indicative of fetal heartbeats.

5. The automatic fetal monitoring system of claim 1

further comprising adaptive signal cancellation means for adaptively cancelling at least a portion of at least one cardiac sensor signal to increase the strength of signals indicative of fetal heartbeats, said adaptive signal cancellation means including at least one sensor means which is mounted to selectively sense interfering signal components sensed by the fetal cardiac sensor means.

6. The automatic fetal monitoring system of claim 5 wherein

the adaptive signal cancellation means includes sound sensors mounted on said sensor belt which provide signals which are used to adaptively cancel extraneous noise portions of the plurality of cardiac sensor signals in order to emphasize fetal cardiac signal portions thereof.

7. The automatic fetal monitoring system of claim 1 wherein there are a plurality of fetal movement sensor means arranged at spaced positions on said sensor garment to detect fetal movements when the fetus is in a variety of positions within the mother.

8. The automatic fetal monitoring system of claim 7 wherein the sensor garment is a belt having a girth which extends about the torso of the mother, and an enlarged abdominal area for extending over the mother'"'"'s abdomen;

and wherein a plurality of said cardiac and movement sensor means are mounted within the enlarged abdominal area for sensing adjacent to the mother'"'"'s abdomen.

9. The automatic fetal monitoring system of claim 8

further comprising a control unit which incorporates said computing means and said means to perform at least one analysis relating fetal heart rate and detected movement by the fetus;

and

wherein the sensor garment detachably mounts the control unit.

10. The automatic fetal monitoring system of claim 8 wherein the sensor garment is made from a stretchable material.

11. The automatic fetal monitoring system of claim 1 further comprising:

memory means electrically connected to transmit data to the computer means and for storing health related information relating to the mother or fetus; and

display means electrically connected to the memory means, for allowing stored health related information to be visually displayed.

12. The automatic fetal monitoring system of claim 1 further comprising breech position analyzer means electrically connected to the computer means for analyzing the relative strength of signals produced by the plurality of fetal cardiac sensors and for providing a breech position signal;

and

breech position indicating means for indicating when the breech position analyzer has produced a breech position signal indicative of increased probability that a fetus is in a breech position.

13. The automatic fetal monitoring system of claim 1 further comprising sustained absence of fetal movement analyzer means for analyzing to determine whether the fetal movement sensor has failed to detect fetal movement for a predetermined period of time, and means for indicating that no fetal movement has been sensed for such predetermined period of time.

14. The automatic fetal monitoring system of claim 1 further comprising means for comparing fetal heart rate information to at least one preprogrammed threshold;

and indicator means for indicating that fetal heart rate information is outside of the preprogrammed threshold.

15. The automatic fetal monitoring system of claim 1 further comprising a multiple fetus analyzer means electrically connected to the computer means for analyzing the relative strengths of fetal cardiac sensor signals from the plurality of fetal cardiac sensor means;

and multiple fetus indicator means electrically connected to said multiple fetus analyzer means for indicating increased probability that multiple fetuses are present in the mother.

16. The automatic fetal monitoring system of claim 1 further comprising:

memory means electrically connected to transmit data to said computer means for storing health related information relating to the motor or fetus;

display means electrically connected to the memory means for allowing stored health related information to be visually displayed;

breech position analyzer means electrically connected to the computer means for analyzing the relative strength of signals produced by the plurality of fetal cardiac sensors and providing a breech position signal;

breech position indicating means for indicating when the breech position analyzer has produced a breech position signal indicative of increased probability that a fetus is in a breech position;

sustained absence of fetal movement analyzer means electrically connected to the computer means for analyzing to determine whether the fetal movement sensor has failed to detect fetal movement for a predetermined period of time, and means for indicating that no fetal movement has been sensed for such predetermined period of time;

means for comparing fetal heart rate information to at least one preprogrammed threshold; and

indicator means for indicating that fetal heart rate information is outside of the preprogrammed threshold; and

multiple fetal analyzer means electrically connected to the computer means for analyzing the relative strengths of fetal cardiac sensor signals from the plurality of fetal cardiac sensor means; and

multiple fetus indicator means electrically connected to said multiple fetus analyzer means for indicating increased probability that multiple fetuses are present in the mother.

17. An ambulatory, non-invasive, automatic fetal monitoring system for portable use on a mother to continuously measure and analyze information indicative of the well-being of a fetus living within the mother, comprising:

a plurality of fetal cardiac sensor means for detecting fetal heartbeats when the fetus is in a variety of positions within the mother and providing a plurality of electronic fetal cardiac sensor signals which are indicative of fetal heartbeats as perceived from the plurality of fetal cardiac sensor means;

at least one fetal movement sensor means for detecting physical movement of the fetus within the mother and providing an electronic fetal movement sensor signal which is indicative of fetal movement;

a sensor belt for extending about a torso of the mother and positioning the plurality of fetal cardiac sensors and the at least one fetal movement sensor in close proximity to the mother'"'"'s abdomen when the sensor belt is properly worn;

a digital system including at least one microprocessor means and memory means for analyzing said cardiac and movement sensor signals to determine fetal heart rate and including means for analyzing whether fetal heart rate has accelerated immediately after movement by the fetus; and

fetal heart rate indicator means for indicating fetal heart rate; and

indicator means for indicating whether fetal heart rate has accelerated immediately after fetal movement.

18. The automatic fetal monitoring system of claim 17 further comprising:

programmable means for storing health related information concerning the mother or fetus in said memory means; and

display means electrically connected to said memory means for allowing stored health related information to be visually displayed.

19. The automatic fetal monitoring system of claim 17 further comprising breech position analyzer means for analyzing the relative strength of signals produced by the plurality of fetal cardiac sensors and for providing a breech position signal;

and breech position indicating means for indicating when the breech position analyzer has produced a breech position signal indicative of increased probability that a fetus is in a breech position.

20. The automatic fetal monitoring system of claim 17 further comprising a sustained absence of fetal movement analyzer means for analyzing to determine whether the fetal movement sensor has failed to detect movement for a predetermined period of time, and means for indicating that no fetal movement has been sensed for such predetermined period of time.

21. The automatic fetal monitoring system of claim 17 further comprising means for comparing fetal heart rate information to at least one preprogrammed threshold;

and indicator means for indicating that fetal heart rate information is outside of the preprogrammed threshold.

22. The automatic fetal monitoring system of claim 17 further comprising a multiple fetal analyzer means electrically connected to the computer means for analyzing the relative strengths of fetal cardiac sensor signals from the plurality of fetal cardiac sensor means;

and multiple fetus indicator means electrically connected to said multiple fetus analyzer means for indicating increased probability that multiple fetuses are present in the mother.

23. A non-invasive, automatic multiple fetus monitoring system for continuous use on a mother to indicate a likelihood that multiple fetuses are present within the mother, comprising:

a sensor garment for wear by the mother about the mother'"'"'s abdomen;

a plurality of fetal cardiac sensor means mounted on said garment at spaced locations to continuously detect fetal heartbeats when the fetus is in a variety of positions within the mother and provide electronic fetal cardiac sensor signals which are indicative of fetal heartbeats with time;

a computing means connected to receive and analyze said fetal cardiac sensor signals;

said computing means including memory means and means for comparing measured fetal cardiac sensor signal strengths from the plurality of fetal cardiac sensors against preprogrammed criteria indicating an increased likelihood of multiple fetuses; and

multiple fetus indicator means for indicating increased probably that multiple fetuses are present.

24. A multiple fetus monitoring system according to claim 23 and further comprising adaptive signal cancellation means for adaptively cancelling at least a portion of at least one of said cardiac sensor signals to increase the strength of signals indicative of fetal heartbeats.

25. A multiple fetus monitoring system according to claim 23 and further comprising adaptive signal cancellation means for adaptively cancelling at least a portion of at least one cardiac sensor signal to increase the strength of signals indicative of fuel heartbeats, said adaptive signal cancellation means including at least one sensor means which is mounted to selectively sense interfering signal components sensed by the fetal cardiac sensor means.

26. A multiple fetus monitoring system according to claim 25 wherein said means for comparing measured fetal cardiac sensor signal strengths from the plurality of fetal cardiac sensors against preprogrammed criteria performs an analysis which indicates relatively lower correlation of fetal heartbeats to a preprogrammed threshold correlation value.

27. A non-invasive, automatic breech position detector for continuous use on a mother to indicate a likelihood that a fetus has assumed a breech position in the mother'"'"'s womb, comprising:

a sensor garment for wear by the mother about the mother'"'"'s abdomen;

a plurality of fetal cardiac sensors mounted on said sensor garment at a plurality of spaced positions for detecting fetal heartbeats and providing electronic fetal cardiac sensor signals;

computing means electrically connected to receive and analyze said fetal cardiac sensor signals;

said computing means including memory means and means for analyzing said fetal cardiac sensor signals to compare measured fetal cardiac sensor signal strength against preprogrammed criteria indicating an increased likelihood of breech position for at least one combination of relative signal strengths for the plurality of cardiac sensor signals, and for producing a breech position signal; and

breech position indicator means for indicating when the breech position signal has been produced.

28. An automatic breech position detector according to claim 27 and further comprising adaptive signal cancellation means for adaptively cancelling at least a portion of at least one fetal cardiac sensor signal to increase the strength of signals indicative of fetal heartbeats.

29. An automatic breech position detector according to claim 36 and further comprising a multiple fetus monitoring system according to claim 32 and further comprising adaptive signal cancellation means for adaptively cancelling at least a portion of at least one cardiac sensor signal to increase the strength of signals indicative of fetal heart beats, said adaptive signal cancellation means including at least one sensor means which is mounted to selectively sense interfering signal components sensed by the fetal cardiac sensor means.