Wireless pregnancy monitor

• US 10,278,581 B2
• Filed: 07/31/2014
• Issued: 05/07/2019
• Est. Priority Date: 08/08/2013
• Status: Active Grant

• Current Assignee: Bloom Technologies NV
• Original Assignee: Bloom Technologies NV
• Inventors: Gaster, Richard S.
• Primary Examiner(s): Carey, Michael J
• Application Number:
  US14/909,739
• Publication Number:
  US 20160157717A1
• Time in Patent Office: 1,741 Days
• Field of Search: 600300, 600301, 600511
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/06 Arrangements of multiple sensors of different types
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 5/0011 Foetal or obstetric data
• CPC Class Codes: A61B 5/02411 of foetuses
• CPC Class Codes: A61B 5/02416 using photoplethysmograph signals, e.g. generated by infrared radiation A61B5/14552 takes precedence
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• 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 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/6833 Adhesive patches
• 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 8/02 Measuring pulse or heart rate
• CPC Class Codes: A61B 8/0866 involving foetal diagnosis; pre-natal or peri-natal diagnosis of the baby
• CPC Class Codes: A61B 8/488 involving Doppler signals

Abstract

A apparatus for automatically detecting a pregnancy status of a patient include a patch for adhering to human skin, a uterine contraction sensor, such as electromyography (EMG), coupled to the patch with at least two electrodes, and an inertial sensor for sensing fetal movement, or Fetal Heart Rate (FHR) sensor, such as Fetal EKG or a Doppler Ultrasound. An electronic circuit is coupled to the patch, the EMG sensor and the inertial sensor, and/or FHR sensor. The circuit provides an output based on a uterine contraction signal from the EMG sensor (or Doppler ultrasound) correlated in time to a fetal movement, and/or fetal heart rate. The apparatus may include a thermometer to aid in automatically providing an indication of a pregnancy complication or ovulation status of the patient, based on the output.

Claims

1. An apparatus for automatically detecting a pregnancy status of a patient, the apparatus comprising:

a patch of material having a proximal side configured for adhering to human skin and a distal side opposite to the proximal side;

a uterine contraction monitor coupled to the patch of material and configured for sensing uterine contractions when the proximal side is adhered to skin of a patient;

a fetal heart rate (FHR) sensor coupled to the patch of material and configured for detecting a FHR signal when the proximal side is adhered to skin of the patient; and

an electronic circuit coupled to the patch of material, the uterine contraction monitor, and the FHR sensor, the electronic circuit comprising a processor, wherein the apparatus is configured to;

detect contractions from a signal received from the uterine contraction monitor;

analyze a strength, a duration, and a frequency of the contractions;

detect an FHR from the FHR signal received from the FHR sensor;

determine whether there is an early deceleration, a late deceleration, an acceleration, a variable deceleration, or a change in the FHR signal;

correlate, based on time, the signal from the uterine contraction monitor to the FHR signal from the FHR sensor; and

automatically output to the patient an indication of a pregnancy status and one or more of fetal movement, normal fetal status, and fetal distress based on said correlation.

2. The apparatus of claim 1, wherein the electronic circuit comprises a wireless transmitter for wirelessly transmitting signals to a remote device.

3. The apparatus of claim 2, wherein the electronic circuit comprises a wireless receiver configured for receiving the pregnancy status from the remote device.

4. The apparatus of claim 1, wherein the patch of material comprises separate pieces, wherein each of the separate pieces includes at least one component coupled to the electronic circuit.

5. The apparatus of claim 1, wherein the processor is coupled to a memory, the memory holding instructions that when executed by the processor cause the electronic circuit to analyze the detected contractions.

6. The apparatus of claim 1, further comprising an inertial sensor coupled to the patch of material and configured for sensing fetal movement when the proximal side is adhered to skin of the patient.

7. The apparatus of claim 6, wherein the processor is further configured to provide an output based on an inertial motion signal from the inertial sensor.

8. The apparatus of claim 1, further comprising a temperature sensor, wherein the processor is further configured to provide an output based on a temperature signal from the temperature sensor.

9. The apparatus of claim 1, wherein the FHR sensor is selected from:

a Doppler ultrasound probe, an optical sensor providing output signal for photoplethysmography, and a set of electrodes arranged for providing an electrocardiographic (EKG) signal.

10. The apparatus of claim 1, further comprising a housing enclosing the electronic circuit and disposed on the distal side of the patch of material.

11. The apparatus of claim 1, further comprising an electronic display coupled to the electronic circuit, the electronic display configured for displaying an indication of a current pregnancy status.

12. The apparatus of claim 1, further comprising an audio transducer coupled to the electronic circuit, the audio transducer configured for providing an audible indication of a current pregnancy status.

13. The apparatus of claim 1, wherein the patch is comprised of a pliable material.

14. The apparatus of claim 9, wherein one or both of the uterine contraction monitor and the FHR sensor comprise a Doppler ultrasound sensor.

58. The apparatus of claim 1, wherein said correlating comprises correlating, based on time, the frequency of the contractions to the FHR signal from the FHR sensor.

15. A method for automatically detecting a pregnancy status of a patient, the method comprising:

coupling an apparatus to an abdomen of a patient, the apparatus comprising a patch of material, a uterine contraction monitor coupled to the patch of material, a fetal heart rate (FHR) sensor coupled to the patch of material, and an electronic circuit coupled to the patch of material, wherein the apparatus further comprises a processor, and wherein the apparatus is configured to;

detect contractions from a signal received from the uterine contraction monitor;

analyze a strength, a duration, and a frequency of the contractions;

detect an FHR from an FHR signal received from the FHR sensor;

determine whether there is an early deceleration, a late deceleration, an acceleration, a variable deceleration, or a change in the FHR signal;

correlate, based on time, the signal from the uterine contraction monitor to the FHR signal from the FHR sensor; and

automatically output to the patient an indication of a pregnancy status and one or more of fetal movement, normal fetal status, and fetal distress based on said correlation.

16. The method of claim 15, wherein the apparatus is further configured to wirelessly transmit signals to a remote device.

17. The method of claim 16, wherein the apparatus is further configured to receive the pregnancy status from the remote device, and output the indication of the pregnancy status from at least one of a display device or a transducer in a human-perceptible form.

18. The method of claim 15, wherein analyzing the strength, the duration, and the frequency is performed using the processor coupled to the electronic circuit.

19. The method of claim 15, wherein analyzing the strength, the duration, and the frequency is performed using a second processor located in a remote device.

20. The method of claim 19, wherein the apparatus is further configured to output the indication of the pregnancy status from the remote device.

21. The method of claim 20, wherein the remote device comprises at least one of a smartphone or a tablet computer.

22. The method of claim 15, wherein the patch further comprises an inertial sensor configured for sensing fetal movement, and the method further comprises providing an indication of the pregnancy status further based on an inertial motion signal from the inertial sensor.

23. The method of claim 15, wherein the patch further comprises an inertial sensor configured for sensing fetal movement, and the apparatus is further configured to provide a separate indication of the pregnancy status based on an inertial motion signal from the inertial sensor excluding the signal received from the uterine contraction monitor.

24. The method of claim 15, wherein the patch further comprises a temperature sensor, and the apparatus is further configured to provide the indication of the pregnancy status further based on a temperature signal from the temperature sensor.

25. The method of claim 15, wherein the FHR sensor is selected from:

a Doppler ultrasound probe, an optical sensor providing a photoplethysmographic signal, and a set of electrodes providing an electrocardiographic (EKG) signal.

26. The method of claim 15, wherein the apparatus is further configured to provide an indication of onset of labor based on an intensity the strength, the duration and the frequency of contractions detected by the uterine contraction monitor.

27. The method of claim 15, wherein the apparatus is further configured to indicate the normal fetal status based on detecting the acceleration of the FHR for a period less than a defined time threshold correlated to a sensor input indicating fetal movement.

28. The method of claim 15, wherein the early deceleration in the FHR signal occurs gradually from an onset of the contraction for a period less than a defined time threshold and returns to a baseline FHR after the contraction, indicating the normal fetal status.

29. The method of claim 15, wherein the apparatus is further configured to indicate a fetal hypoxemia status based on detecting the late deceleration wherein the FHR signal gradually drops after onset of the contraction for a period greater than a defined time threshold and that returns to a baseline FHR after the contraction.

30. The method of claim 29, further comprising accompanying the indication of the fetal hypoxemia status with a warning advising medical attention.

31. The method of claim 15, wherein the apparatus is further configured to indicate an umbilical cord compression status based on detecting the variable deceleration in the FHR signal wherein the FHR signal abruptly drops at an onset of the contraction over a period less than a defined time threshold and remains depressed for a second period greater than a second defined time threshold.

32. The method of claim 15, wherein one or both of the uterine contraction monitor and the FHR sensor comprise a Doppler ultrasound sensor.

59. The method of claim 15, wherein the apparatus is further configured to:

detect the early deceleration in the FHR, wherein the early deceleration comprises a gradual drop at an onset of the contraction, with onset to nadir for a period greater than a defined time threshold, and a return to baseline that mirrors the contraction; and

output the normal fetal status indicating that a fetal head is vertex.

33. An apparatus for automatically detecting a pregnancy status of a patient, the apparatus comprising:

a patch of material having a proximal side configured for adhering to human skin and a distal side opposite to the proximal side;

an electromyography (EMG) sensor coupled to the patch of material, the EMG sensor comprising at least two electrodes disposed toward the proximal side of the patch of material and configured for sensing uterine contractions when the proximal side is adhered to skin of a patient;

a fetal heart rate (FHR) sensor coupled to the patch of material and configured for detecting an FHR signal when the proximal side is adhered to skin of the patient; and

an electronic circuit coupled to the patch of material, the EMG sensor, and the FHR sensor, the electronic circuit comprising a processor, wherein the apparatus is configured to;

detect contractions from a signal received from the EMG sensor;

analyze a strength, a duration, and a frequency of the contractions;

detect an FHR from the FHR signal received from the FHR sensor;

determine whether there is an early deceleration, a late deceleration, an acceleration, a variable deceleration, or a change in the FHR signal;

correlate, based on time, the signal from the EMG sensor to the FHR signal from the FHR sensor; and

automatically output to the patient an indication of a pregnancy status and one or more of fetal movement, normal fetal status, and fetal distress based on said correlation.

34. The apparatus of claim 33, wherein the electronic circuit comprises a wireless transmitter for wirelessly transmitting signals to a remote device.

35. The apparatus of claim 34, wherein the electronic circuit comprises a wireless receiver configured for receiving the pregnancy status from the remote device.

36. The apparatus of claim 33, wherein the patch of material comprises separate pieces, wherein each of the separate pieces includes at least one component coupled to the electronic circuit.

37. The apparatus of claim 33, wherein the processor is coupled to a memory, the memory holding instructions that when executed by the processor cause the processor to analyze the detected contractions.

38. The apparatus of claim 33, further comprising a temperature sensor, wherein the processor is further configured to provide an output further based on a temperature signal from the temperature sensor.

39. The apparatus of claim 33, further comprising an inertial sensor, wherein the inertial sensor is selected from:

a Doppler ultrasound probe, an optical sensor providing output signal for photoplethysmography, and a set of electrodes arranged for providing an electrocardiographic (EKG) signal.

40. The apparatus of claim 33, further comprising a housing enclosing the electronic circuit and disposed on the distal side of the patch of material.

41. The apparatus of claim 33, further comprising an electronic display coupled to the electronic circuit, the electronic display configured for displaying an indication of a current pregnancy status.

42. The apparatus of claim 33, further comprising an audio transducer coupled to the electronic circuit, the audio transducer configured for providing an audible indication of a current pregnancy status.

43. The apparatus of claim 33, wherein the patch is comprised of a pliable material.

44. A method for automatically detecting a pregnancy status of a patient, the method comprising:

coupling, to an abdomen of a patient, an apparatus comprising a patch of material, an electromyography (EMG) sensor, a fetal heart rate (FHR) sensor, and an electronic circuit coupled to the patch of material and comprising a processor, wherein the apparatus is configured to;

detect contractions from an EMG signal received from the EMG sensor;

analyze a strength, a duration, and a frequency of the contractions;

detect an FHR from an FHR signal received from the FHR sensor;

determine whether there is an early deceleration, a late deceleration, an acceleration, a variable deceleration, or a change in the FHR signal;

correlate, based on time, the EMG signal from the EMG sensor to the FHR signal from the FHR sensor; and

automatically output to the patient an indication of a pregnancy status and one or more of fetal movement, normal fetal status, and fetal distress based on said correlation.

45. The method of claim 44, further comprising wirelessly transmitting signals to a remote device.

46. The method of claim 45, further comprising receiving the pregnancy status from the remote device, and outputting the indication of the pregnancy status from at least one of a display device or a transducer in a human-perceptible form.

47. The method of claim 44, wherein analyzing the strength, the duration, and the frequency is performed using the processor coupled to the patch.

48. The method of claim 44, wherein analyzing the strength, the duration, and the frequency is performed using a second processor located in a remote device.

49. The method of claim 48, further comprising outputting the indication of the pregnancy status from the remote device.

50. The method of claim 48, wherein the remote device comprises at least one of a smartphone or a tablet computer.

51. The method of claim 44, wherein the apparatus further comprises a temperature sensor, and the apparatus is further configured to provide the indication of the pregnancy status further based on a temperature signal from the temperature sensor.

52. An apparatus for automatically detecting a pregnancy status of a patient, the apparatus comprising:

a patch of material having a proximal side configured for adhering to human skin and a distal side opposite to the proximal side;

a Doppler ultrasound sensor coupled to the patch of material, configured for sensing a fetal heart rate (FHR) and uterine contractions when the proximal side is adhered to skin of a patient; and

an electronic circuit coupled to the patch of material and the Doppler ultrasound sensor, wherein the electronic circuit comprises a processor configured to;

detect contractions from a contraction signal received from the Doppler ultrasound sensor,

analyze a strength, a duration, and a frequency of the contractions,

detect the FHR from an FHR signal received from the Doppler ultrasound sensor,

determine whether there is an early deceleration, a late deceleration, an acceleration, a variable deceleration, or a change in the FHR signal,

correlate, based on time, the contraction signal to the FHR signal from the FHR sensor Doppler ultrasound sensor, and

automatically output to the patient an indication of a pregnancy status and one or more of fetal movement, normal fetal status, and fetal distress based on said correlation.

53. The apparatus of claim 52, wherein the electronic circuit comprises a wireless transmitter and the processor is further configured to wirelessly transmit signals to a remote device.

54. The apparatus of claim 53, wherein the electronic circuit comprises a wireless receiver configured to receive the pregnancy status from the remote device.

55. An apparatus for automatically detecting a pregnancy status of a patient, the apparatus comprising:

a patch of material having a proximal side configured for adhering to human skin and a distal side opposite to the proximal side;

a wearable biosensor coupled to the patch of material, configured for sensing uterine contractions and fetal heart rate (FHR) when the proximal side is adhered to skin of a patient; and

an electronic circuit coupled to the patch of material and the wearable biosensor, wherein the electronic circuit comprises a processor configured to;

detect contractions from a contraction signal received from the wearable biosensor,

analyze a strength, a duration, and a frequency of the contractions,

detect the FHR from an FHR signal received from the wearable biosensor,

determine whether there is an early deceleration, a late deceleration, an acceleration, a variable deceleration, or a change in the FHR signal,

correlate, based on time, the contraction signal to the FHR signal from the wearable biosensor, and

automatically output to the patient an indication of a pregnancy status and one or more of fetal movement, normal fetal status, and fetal distress based on said correlation.

56. The apparatus of claim 55, wherein the electronic circuit comprises a wireless transmitter and the processor is configured to wirelessly transmit signals to a remote device.

57. The apparatus of claim 56, wherein the electronic circuit comprises a wireless receiver configured to receive the pregnancy status from the remote device.