WEARABLE FETAL MONITORING SYSTEM HAVING TEXTILE ELECTRODES

• US 20160128594A1
• Filed: 06/01/2014
• Published: 05/12/2016
• Est. Priority Date: 06/01/2013
• Status: Active Grant

• Current Assignee: HealthWatch Ltd
• Original Assignee: HealthWatch Ltd
• Inventors: MALAFRIEV, Oleg, AMIR, Uri, KATZ, Itzhak
• Granted Patent: US 9,591,983 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A41D 1/002 adapted to accommodate electronic equipment patients' garments for medical monitoring A41D13/1281; luminous ornaments A41D27/085
• CPC Class Codes: A41D 1/21 Maternity clothing; Clothing specially adapted for persons caring for infants
• CPC Class Codes: A41D 2500/10 Knitted
• CPC Class Codes: A41D 2500/20 Woven
• CPC Class Codes: A61B 2503/02 Foetus
• CPC Class Codes: A61B 2562/0209 Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
• CPC Class Codes: A61B 2562/04 Arrangements of multiple sensors of the same type
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0011 Foetal or obstetric data
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/02411 of foetuses
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• 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 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/288 : for foetal cardiography, e.g. scalp electrodes
• CPC Class Codes: A61B 5/344 : Foetal cardiography
• CPC Class Codes: A61B 5/349 : Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/366 : Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61B 5/389 : Electromyography [EMG]
• CPC Class Codes: A61B 5/6804 : Garments; Clothes
• CPC Class Codes: A61B 5/6805 : Vests
• CPC Class Codes: A61B 5/6823 : Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/7203 : for noise prevention, reduction or removal
• 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

Abstract

A seamless, smart fetal monitoring garment and methods of using thereof. The system includes a knitted or interwoven garment having a multiplicity of conductive textile electrodes for sensing maternal and fetal electrical vital signals. The maternal and fetal electrical vital signals are selected from a group including maternal heart rate, fetal heart rate and electromyogram (EMG) activities including uterine activities. The method includes wearing the garment, acquiring electrical mixed common, maternal and fetal vital signals from surface region of a pregnant woman, using the plurality of textile electrodes, optimally weighted summing-up the acquired signals, analyzing the summed-up signals to thereby extract the maternal signal and the fetal signal, including determining their heart rates, and including detecting health hazards and in some embodiments, including detecting a uterine contraction sequence suggesting the need to be hospitalized for birth giving.

Claims

1. A smart maternal monitoring garment comprising:

a) a tubular form having variable elasticity, said tubular form having a first multiplicity of knitted or interwoven lines, wherein each said line is knitted or interwoven with at least one non-conductive yarn; and

b) a second multiplicity of conductive textile electrodes for sensing maternal and fetal electrical vital signals, each said conductive textile electrode having;

i. a third multiplicity of vertically-aligned line segments, wherein each said segment is formed within said knitted or interwoven lines with a non-conductive yarn and a conductive yarn; and

ii. a skin-side face configured to electrically conduct said signal from a predetermined external surface region of a pregnant woman,

wherein each said conductive textile electrode is adapted to be in communication flow with a processor.

2. The maternal garment of claim 1, wherein said maternal and fetal electrical vital signals are selected from a group including maternal heart rate, fetal heart rate and electromyogram (EMG) activities including uterine activities.

3. The maternal garment of claim 1, wherein said predetermined external surface region is selected from a group including the abdomen, the perineum and buttocks of said pregnant woman.

4. The maternal garment of claim 1, wherein said second multiplicity of conductive textile electrodes includes a preconfigured number of measuring electrodes and a preconfigured number of reference electrodes.

5. The maternal garment of claim 4, wherein each said measuring electrode is paired with at least one reference electrode.

6. The maternal garment of claim 4, wherein each given said conductive textile electrode, in a specific measurement instance, is paired with a preconfigured number of other said conductive textile electrodes, and

wherein in each said pairing, said given conductive textile electrode serves either as a measuring electrode or as a reference electrode, thereby facilitating increasing the number of differential measurements acquired, in said specific measurement instance, beyond said second multiplicity of said conductive textile electrodes.

7. The maternal garment of claim 4, wherein said measuring electrodes and said reference electrodes are positioned, within the maternal garment, in preconfigured locations.

8. The maternal garment of claim 7, wherein said position of said measuring electrodes and said reference electrodes are preconfigured to thereby optimize the spatial coverage of the uterine.

9. The maternal garment of claim 4, wherein the pairing of said measuring electrodes and respective said reference electrodes is preset using said processor.

10. The maternal garment of claim 9, wherein said number of measuring electrodes, said number of reference electrodes and said pairing thereof are preset to thereby optimize the signal to noise (SNR) ratio.

11. The maternal garment of claim 1, wherein said tubular form has a designated knitting or interweaving density, and

wherein one or more designated regions have a knitting or interweaving density that is higher than said designated knitting or interweaving density of said tubular form, thereby providing said variable elasticity, to enable stable conductive contact of said skin-side face of each said electrode with the skin of said pregnant woman.

12. The maternal garment of claim 1, wherein said maternal and fetal monitoring is performed continuously, day and night, while performing everyday life chores.

13. The maternal garment of claim 1, wherein said processor is adapted to alert at least one preconfigured receiving entity, upon detecting a health hazard.

14. The maternal garment of claim 1, wherein said conductive textile electrode are in communication flow with the processor via conductive stripes or line traces;

wherein the tubular form further includes a generally vertical zipper; and

wherein said conductive stripes or line traces are attached to or knitted into said smart garment in a path that is set to continuously pass through the continuous section of the garment between the two unzipped parts of said zipper.

15. The maternal garment of claim 13, wherein said preconfigured receiving entity is selected from the group including a smart personal electronic device of said pregnant woman, a smart personal electronic device of another person, a medical personal, and a computerized center.

16. A method for maternal and fetal monitoring comprising the steps of:

a) wearing a knitted or interwoven smart maternal garment having a plurality of textile electrodes integrally knitted or interwoven therein, said textile electrodes being in communication flow with a processor;

b) acquiring electrical mixed common, maternal and fetal electrical vital signals from a predetermined external surface region of a pregnant woman, using a plurality of textile electrodes integrally knitted or interwoven into a maternal garment;

c) optimally weighted summing-up said acquired mixed maternal and fetal electrical vital signals to thereby form a summed-up mixed signal, having a substantially higher SNR than either of the acquired maternal and fetal electrical vital signals;

d) analyzing the summed-up mixed signal to thereby extract the maternal signal from said summed-up mixed signal and maternal-related-parameters thereof; and

e) healing the summed-up mixed signal, including deleting the extracted maternal signal from said summed-up mixed signal, to thereby form a healed-summed-up mixed signal;

f) analyzing said healed-summed-up mixed signal to thereby extract a fetal signal from said healed-summed-up mixed signal and fetal-related-parameters thereof.

17. The method of claim 16, wherein said maternal-related-parameters are selected from the group including heart rate, oxygen saturation, respiratory rate, blood pressure, skin temperature and ECG parameters such as ST elevation and depression.

18. The method of claim 16, wherein said fetal-related-parameters are selected from the group including heart rate, spatial position of the heart inside the womb, body spatial orientation inside the womb, motion inside the womb and body dimensions.

19. A method for maternal and fetal monitoring comprising the steps of:

a) wearing a knitted or interwoven smart maternal garment having a plurality of textile electrodes integrally knitted or interwoven therein, said textile electrodes being in communication flow with a processor;

b) acquiring electrical mixed common, maternal and fetal electrical vital signals from a predetermined external surface region of a pregnant woman, using a plurality of textile electrodes integrally knitted or interwoven into a maternal garment;

c) optimally weighted summing-up said acquired mixed maternal and fetal electrical vital signals to thereby form a summed-up maternal signal, having a substantially higher SNR than either of the acquired maternal and fetal electrical vital signals;

d) analyzing the summed-up maternal signal to thereby extract the maternal signal from said summed-up maternal signal; and

e) healing the acquired mixed maternal and fetal electrical vital signals, including deleting the extracted maternal signal from the respective acquired mixed maternal and fetal electrical vital signal, to thereby form a plurality of healed-maternal ECG signals;

f) optimally weighted summing-up said healed-maternal ECG signals to thereby form a summed-up coherent fetal signal, having a substantially higher SNR than either of the healed-maternal ECG signals;

g) analyzing said summed-up coherent fetal signal to thereby extract a fetal signal from said summed-up coherent fetal signal.

20. The method of claim 19 further comprising the step of:

h) analyzing said summed-up coherent fetal signal thereby extract the EMG signal formed by electromyogram (EMG) activities including uterine activities, from said summed-up coherent fetal signal.

21. The method of claim 19, wherein said extracting and analyzing of said maternal signal from said summed-up electrical signal comprises the steps of:

a) detecting the peaks in the maternal QRS complexes using said summed-up maternal signal, the maternal QRS complexes peaks being substantially stronger than the fetal QRS complexes;

b) determining the boundary of each said detected maternal QRS complex;

c) analyzing said summed-up maternal signal to thereby extract said maternal signal and determine the maternal HR; and

d) analyzing each said detected maternal QRS complex to thereby detect health hazardous data.

22. The method of claim 19, wherein said extracting and analyzing of said fetal signal from said summed-up electrical signal comprises the steps of:

a) detecting the peaks in the maternal QRS complexes in said summed-up maternal signal, the maternal QRS complexes peaks being substantially stronger than the fetal QRS complexes;

b) determining the boundary of each said detected maternal QRS complex;

c) deleting each said detected maternal QRS complex from the respective said acquired mixed maternal and fetal electrical vital signal and filling the gap formed therein, thereby forming a respective healed-maternal ECG signal;

d) optimally-weighted summing-up said healed-maternal ECG signals to thereby form a summed-up coherent fetal signal, having a substantially higher SNR than either of said healed-maternal ECG signals;

e) detecting the peaks of fetal QRS complexes in said summed-up coherent fetal signal;

f) determining the boundary of each said detected fetal QRS complex;

g) analyzing said summed-up maternal signal to thereby extract said fetal signal and determine the fetal HR; and

h) analyzing each said detected fetal QRS complex to thereby detect health hazardous data.

23. The method of claim 20, wherein said extracting and analyzing of said EMG signal from said summed-up electrical signal comprises the steps of:

a) detecting the peaks in the maternal QRS complexes in said summed-up maternal signal;

b) determining the boundary of each said detected maternal QRS complex;

c) deleting each said detected maternal QRS complex from the respective acquired mixed maternal and fetal electrical vital signal and filling the gap formed therein, thereby forming a respective healed-maternal ECG signal;

d) detecting the peaks of fetal QRS complexes in said summed-up coherent fetal signal;

e) determining the boundary of each said detected fetal QRS complex;

f) deleting each said detected fetal QRS complex from the summed-up coherent fetal signal and filling the gap formed therein, thereby forming a EMG summed-up signal; and

g) analyzing the EMG summed-up signal.

24. The method of claim 22, wherein said filling of said gap includes by using linear interpolation or spline.

25. The method of claim 23, wherein said analysis of said EMG summed-up signal includes performing a morphologically analysis to thereby determine if the uterine is contracting at a rate and amplitude that requires hospitalization for birth giving.

26. The method of claim 22, wherein said summed-up coherent fetal signal contains more than one fetus and wherein said fetal QRS complexes of the signal of each fetus is separated based on different heart rate and/or different phase normal or inverted QRS Complex.

27. The method of claim 26, wherein said separation of the signal of each fetus is performed using Fourier transform.

28. The method of claim 19, wherein said maternal garment is worn without attaching either of said electrodes,

regardless of the precise bodily positioning of each said electrode;

regardless of the chronological stage of the pregnancy; and

regardless of the amount of stretching of the tubular form and of each said electrode.

29. The method of claim 19, wherein said maternal signal includes maternal heart rate.

30. The method of claim 19, wherein said fetal signal includes fetal heart rate.

31. The method of claim 19, wherein said predetermined external surface region is selected from a group including the abdomen, the perineum and buttocks of said pregnant woman.

32. The method of claim 19, wherein said conductive textile electrodes include a preconfigured number of measuring electrodes and a preconfigured number of reference electrodes.

33. The maternal garment of claim 32, wherein each said measuring electrode is paired with at least one reference electrode.

34. The method of claim 32, wherein each given said conductive textile electrode, in a specific measurement instance, is paired with a preconfigured number of other said conductive textile electrodes, and wherein in each said pairing, said given conductive textile electrode serves either as a measuring electrode or as a reference electrode, thereby facilitating increasing the number of differential measurements acquired, in said specific measurement instance, beyond said second multiplicity of said conductive textile electrodes.

35. The method of claim 32, wherein said measuring electrodes and said reference electrodes are positioned, within the maternal garment, in preconfigured locations.

36. The method of claim 35, wherein said position of said measuring electrodes and said reference electrodes are preconfigured to thereby optimize the spatial coverage of the uterine.

37. The method of claim 32, wherein the pairing of said measuring electrodes and respective said reference electrodes are preset using said processor.

38. The method of claim 37, wherein said number of measuring electrodes, said number of reference electrodes and said pairing thereof are preset to thereby optimize the signal to noise (SNR) ratio.

39. The method of claim 23, wherein said filling of said gap includes by using linear interpolation or spline.