Non-invasive fetal monitoring

• US 8,892,181 B2
• Filed: 10/17/2012
• Issued: 11/18/2014
• Est. Priority Date: 10/21/2011
• Status: Active Grant

• Current Assignee: MindChild Medical Inc.
• Original Assignee: MindChild Medical Inc.
• Inventors: Wolfberg, Adam J., Ward, Jay, Robertson, James K.
• Primary Examiner(s): Cohen, Lee S
• Application Number:
  US13/653,700
• Publication Number:
  US 20130102857A1
• Time in Patent Office: 762 Days
• Field of Search: 600/376, 600391-393, 600/511
• US Class Current: 600/391
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/344 Foetal cardiography
• CPC Class Codes: A61B 5/6804 Garments; Clothes
• 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 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots

Abstract

A non-invasive fetal monitoring system includes a plurality of contact elements, each of the contact elements comprising a plurality of electrodes configured in a unique pattern. The plurality of contact elements are configured for attachment to an external skin surface of a pregnant female for detecting fetal and/or maternal electrical activity.

Claims

1. A system for monitoring fetal electrical activity, the system comprising:

a plurality of contact elements, each of the plurality of contact elements configured for attachment to an external skin surface of a pregnant female; and

at least two sets of electrodes associated with each of the plurality of contact elements such that electrodes of each set contact the external skin surface of the pregnant female when the associated contact element is attached, the at least two sets of electrodes comprising a first set of electrodes arranged in a first pattern and a second set of electrodes separate from the first set of electrodes and arranged in a second pattern distinct from the first pattern, each of the plurality of contact elements having its sets of electrodes configured in a unique pattern such that at least one electrode from a first contact element and a corresponding electrode from a second contact element form a cross-body lead, fetal electrical activity being detected by the electrodes when the contact elements are attached.

2. The system of claim 1, wherein the fetal electrical activity is indicative of fetal cardiac activity, fetal brain activity, fetal body position, or a combination thereof.

3. The method of claim 1, wherein the plurality of contact elements are each configured for attachment to an external skin surface in the torso region of the pregnant female.

4. The method of claim 3, wherein the plurality of contact elements are each configured for attachment to a different area of the torso.

5. The method of claim 4, wherein the plurality of contact elements are configured for attachment to the abdominal region, the lumbar region and one or more side regions of the torso, or any combination thereof.

6. The system of claim 1 wherein each of the plurality of contact elements comprises a patch.

7. The system of claim 6 wherein the patch comprises a fabric.

8. The system of claim 6 wherein the patch includes an adhesive for adhering to the external skin surface of the pregnant female.

9. The system of claim 1 wherein the electrode pattern of each of the at least two sets of electrodes of each of the contact elements is configured in relation to an anatomical reference point of the pregnant female.

10. The system of claim 9 wherein each of the contact elements includes a reference element to guide attachment of the contact element to the external skin surface of the torso of the pregnant female.

11. The system of claim 9 wherein the anatomical reference point is the maternal heart, the belly button, the iliac arch, or the spine.

12. The system of claim 1 wherein fetal electrical activity is detected by the electrodes when the contact elements are attached regardless of the position of the fetus within the pregnant female.

13. The system of claim 1 wherein a first one of the plurality of contact elements is configured for attachment to the external skin surface of an abdominal region of the torso of the pregnant female and a second one of the plurality of contact elements is configured for attachment to the external skin surface of a lumbar region of the torso of the pregnant female.

14. The system of claim 13 wherein a third one of the plurality of contact elements is configured for attachment to the external skin surface of a right side of the torso of the pregnant female and a fourth one of the plurality of contact elements is configured for attachment to the external skin surface of a left side of the torso of the pregnant female.

15. The system of claim 1 wherein each of the electrode patterns comprises at least two dry electrodes.

16. The system of claim 1 wherein each of the electrode patterns comprises at least two gel-adhesive electrodes.

17. The system of claim 1 wherein each of the electrode patterns comprises at least one dry electrode and at least one gel-adhesive electrode.

18. The system of claim 1, wherein the plurality of contact elements comprise a minimum of 6 electrodes combined between the plurality of contact elements.

19. The system of claim 1, wherein the plurality of contact elements comprises a maximum of 64 electrodes combined between the plurality of contact elements.

20. The system of claim 1, wherein the plurality of contact elements comprise 32 electrodes between the plurality of contact elements.

21. The system of claim 1, wherein each of the at least two sets of electrodes associated with each of the plurality of contact elements is configured in a predetermined pattern.

22. The system of claim 1, wherein one or more of the plurality of contact elements further comprises an electronic identification tag.

23. The system of claim 1, wherein one or more of the plurality of contact elements is configured for long range, wireless transmission of fetal electrical activity.

24. The system of claim 1, wherein the system is configured for a single-use.

25. A system for monitoring fetal electrical activity, the system comprising:

a plurality of contact elements, each of the plurality of contact elements configured for attachment to different areas on the external skin surface of a pregnant female; and

at least two sets of electrodes associated with each of the plurality of contact elements such that electrodes of each set contact the different external skin surface areas of the pregnant female when the associated contact element is attached, the at least two sets of electrodes comprising a first set of electrodes arranged in a first pattern and a second set of electrodes separate from the first set of electrodes and arranged in a second pattern distinct from the first pattern, and at least one electrode from a first contact element and a corresponding electrode from a second contact element form a cross-body lead, fetal electrical activity being detected by the electrodes when the contact elements are attached.

26. The system of claim 25, wherein the fetal electrical activity is indicative of fetal cardiac activity, fetal brain activity, fetal body position, or a combination thereof.

27. The method of claim 25, wherein the plurality of contact elements are each configured for attachment to a different external skin surface areas in the torso region of the pregnant female.

28. The method of claim 27, wherein the plurality of contact elements are configured for attachment to the abdominal region, the lumbar region and one or more side regions of the torso, or any combination thereof.

29. The system of claim 25 wherein each of the plurality of contact elements comprises a patch.

30. The system of claim 29 wherein the patch comprises a fabric.

31. The system of claim 30 wherein the patch includes an adhesive for adhering to the external skin surface of the pregnant female.

32. The system of claim 25 wherein the electrode pattern of each of the contact elements is configured in a unique pattern.

33. The system of claim 25, wherein the electrode pattern of each of the at least two sets of electrodes of each of the contact elements is configured in relation to an anatomical reference point of the pregnant female.

34. The system of claim 33 wherein one or more of the contact elements includes a reference element to guide attachment of the contact element to the particular external skin surface area of the torso of the pregnant female.

35. The system of claim 33 wherein the anatomical reference point is the maternal heart, the belly button, the iliac arch, or the spine.

36. The system of claim 25 wherein fetal electrical activity is detected by the electrodes when the contact elements are attached regardless of the position of the fetus within the pregnant female.

37. The system of claim 25 wherein a first one of the plurality of contact elements is configured for attachment to the external skin surface of an abdominal region of the torso of the pregnant female and a second one of the plurality of contact elements is configured for attachment to the external skin surface of a lumbar region of the torso of the pregnant female.

38. The system of claim 37 wherein a third one of the plurality of contact elements is configured for attachment to the external skin surface of a right side of the torso of the pregnant female and a fourth one of the plurality of contact elements is configured for attachment to the external skin surface of a left side of the torso of the pregnant female.

39. The system of claim 25 wherein each of the electrode patterns comprises at least two dry electrodes.

40. The system of claim 25 wherein each of the electrode patterns comprises at least two gel-adhesive electrodes.

41. The system of claim 25 wherein each of the electrode patterns comprises at least one dry electrode and at least one gel-adhesive electrode.

42. The system of claim 25, wherein the plurality of contact elements comprise a minimum of 6 electrodes combined between the plurality of contact elements.

43. The system of claim 25, wherein the plurality of contact elements comprises a maximum of 64 electrodes combined between the plurality of contact elements.

44. The system of claim 25, wherein the plurality of contact elements comprise 32 electrodes between the plurality of contact elements.

45. The system of claim 25, wherein each of the at least two sets of electrodes associated with each of the plurality of contact elements is configured in a predetermined pattern.

46. The system of claim 25, wherein one or more of the plurality of contact elements further comprises an electronic identification tag.

47. The system of claim 25, wherein one or more of the plurality of contact elements is configured for long range, wireless transmission of fetal electrical activity.

48. The system of claim 25, wherein the system is configured for a single-use.