Non-invasive fetal probe having improved mechanical and electrical properties

• US 5,833,622 A
• Filed: 10/31/1996
• Issued: 11/10/1998
• Est. Priority Date: 04/04/1994
• Status: Expired due to Fees

• Current Assignee: Graphic Controls Corporation (Nissha Co., Ltd.)
• Original Assignee: Graphic Controls Corporation (Nissha Co., Ltd.)
• Inventors: Meathrel, William G., Saleem, Mohammed, Binks, Shirley A., Gusakov, Ignaty
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US08/741,942
• Time in Patent Office: 740 Days
• Field of Search: 128/639-643, 128/698, 607/138, 607/149, 607/152, 607/153, 252/500, 252/521, 424/78.31, 424/78.35, 424/78.37, 424/443, 424/447, 600/511, 600/376
• US Class Current: 600/511
• CPC Class Codes: A61B 5/252 by suction
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/28 for electrocardiography [ECG]
• CPC Class Codes: A61B 5/288 for foetal cardiography, e.g. scalp electrodes
• CPC Class Codes: A61B 5/4362 Assessing foetal parameters

Abstract

A non-invasive fetal probe having enhanced adhesion and electrical isolation for attaching to the presenting part of a fetus and sensing at least one fetal parameter during labor and delivery. In one embodiment of the present invention, the electrical isolation of the fetal probe includes a non-conductive element used in combination with various conductive assemblies made from gel formulations which are polymerized to form a fetal sensor. The non-conductive element in addition to providing physical separation also enhances electrical separation between fetal and maternal sensing elements of the fetal probe. Non-invasive fetal probes having low-profile designs are also provided which help decrease the tendency of the fetal probes to detach caused by forces generated upon the probe by the head of the fetus, the cervix of the mother, or both.

Claims

1. A non-invasive fetal probe adapted for attachment to the presenting part of a fetus and monitoring at least one fetal parameter during labor and delivery, said probe comprising:

a shell having a non-conductive element;

a gel coated on said shell forming a surface for securing the probe to a fetus to be monitored,

a fetal sensor carried by said gel for detecting at least one fetal parameter, said non-conductive element of said shell isolating said fetal sensor from fluids in an environment surrounding the probe;

a maternal sensor carried by said shell for detecting at least one maternal parameter; and

means for communicating the fetal and maternal parameters detected by said fetal sensor and said maternal sensor, respectively, to a monitor.

2. A non-invasive fetal probe as recited in claim 1 wherein said non-conductive element is selected from the group consisting of a non-conductive rim, a ledge, a wall extension, a rim extension, and combinations thereof.

3. A non-invasive fetal probe as recited in claim 2 further comprising an insulating barrier disposed between said shell and said gel.

4. A non-invasive fetal probe as recited in claim 2 wherein said shell is a polymer.

5. A non-invasive fetal probe as recited in claim 2 wherein said non-conductive element is a ledge having a side surface, a top surface, and a bottom surface, said probe further comprising an air gap disposed between said top surface of said ledge and said surface formed by said gel.

6. A non-invasive fetal probe as recited in claim 5 wherein said gel is "V"-shaped.

7. A non-invasive fetal probe as recited in claim 6 wherein said gel has a diameter of 10-20 mm.

8. A non-invasive fetal probe as recited in claim 2 wherein said non-conductive element is a wall extension extending from said shell beyond said surface formed by said gel.

9. A non-invasive fetal probe as recited in claim 2 wherein said fetal sensor is selected from the group consisting of a brush sensor, a disk sensor, a loop array, a conductive fiber wool, a conductive fiber mesh, a conductive fan strand, and combinations thereof.

10. A non-invasive fetal probe as recited in claim 9 wherein said fetal sensor comprises at least one material selected from the group consisting of carbon fibers, stainless steel, silver, gold, silver-silver chloride, and combinations thereof.

11. A non-invasive fetal probe as recited in claim 9 further comprising an adhesion-promoting layer disposed on said fetal sensor.

12. A non-invasive fetal probe as recited in claim 11 wherein said adhesion-promoting layer comprises at least one material selected from the group consisting of a lubricating jelly, a conductive medium, a conductive migrating hydrogel, and combinations thereof.

13. A non-invasive fetal probe as recited in claim 2 wherein said means for communicating comprises a fetal connector connecting said fetal sensor to said monitor and a maternal connector connecting said maternal sensor to said monitor.

14. A non-invasive fetal probe as recited in claim 13 wherein said fetal connector and said maternal connector extend in a radial direction from said shell and each comprise a substantially perpendicular bend.

15. A non-invasive fetal probe as recited in claim 13 wherein said fetal connector and said maternal connector extend in a radial direction from said shell.

16. A non-invasive fetal probe as recited in claim 15 wherein said fetal sensor is a fetal circumferential sensor and said fetal connector is connected to said fetal circumferential sensor.

17. A non-invasive fetal probe as recited in claim 2 wherein said gel further comprises a partially embedded spring contact means adapted for directly contacting the fetus to be monitored upon securing said gel to the presenting part.

18. A non-invasive fetal probe as recited in claim 2 wherein said non-conductive rim is a non-conductive hydrogel adhesive coating formed on said shell.

19. A non-invasive fetal probe as recited in claim 1 wherein said gel is a conductive hydrogel.

20. A non-invasive fetal probe as recited in claim 1 wherein said gel is an adhesive hydrogel.

21. A non-invasive fetal probe as recited in claim 1 wherein said gel is a conductive adhesive hydrogel.

22. A non-invasive fetal probe adapted for attachment to the presenting part of a fetus and monitoring at least one fetal parameter during labor and delivery, said probe comprising:

a shell;

a gel coated on said shell forming a surface for securing the probe to a fetus to be monitored, said shell having an outer perimeter forming a ledge with a side surface, a top surface, and a bottom surface which isolates said gel from fluids in an environment surrounding the probe;

a fetal sensor carried by said gel for detecting at least one fetal parameter; and

an insulating element disposed on said bottom surface of said ledge.

23. A non-invasive fetal probe as recited in claim 22 wherein said insulating element is a non-conductive coating disposed on said bottom surface of said ledge.

24. A non-invasive fetal probe as recited in claim 22 wherein said insulating element is a squeegee having grooves.

25. A non-invasive fetal probe as recited in claim 24 further comprising at least one coating selected from the group consisting of an absorbant coating, a non-conductive adhesive coating, and combinations thereof disposed in said grooves.

26. A non-invasive fetal probe as recited in claim 22 wherein said gel is a conductive hydrogel.

27. A non-invasive fetal probe as recited in claim 22 wherein said gel is an adhesive hydrogel.

28. A non-invasive fetal probe as recited in claim 22 wherein said gel is a conductive adhesive hydrogel.

29. A non-invasive fetal probe attaching to the presenting part of a fetus and monitoring at least one fetal parameter during labor and delivery, said probe comprising:

a gel forming a surface which secures the probe to a fetus to be monitored and has an outer perimeter with a non-conductive rim disposed thereon;

a shell disposed on said gel;

a fetal sensor carried by said gel for detecting at least one fetal parameter; and

means for communicating the fetal parameter detected by said sensor from said sensor to a monitor.

30. A non-invasive fetal probe as recited in claim 29 wherein said non-conductive rim is a non-conductive hydrogel adhesive coating disposed on said outer perimeter of said surface of said gel.

31. A non-invasive fetal probe as recited in claim 29 wherein said gel is bellows-shaped and said non-conductive rim is a non-conductive adhesive supported by a shell disposed on said outer perimeter of said gel.

32. A non-invasive fetal probe as recited in claim 29 wherein said gel is a conductive hydrogel.

33. A non-invasive fetal probe as recited in claim 29 wherein said gel is an adhesive hydrogel.

34. A non-invasive fetal probe as recited in claim 29 wherein said gel is a conductive adhesive hydrogel.

35. A non-invasive fetal probe adapted for attachment to the presenting part of a fetus and monitoring at least one fetal parameter during labor and delivery, said probe comprising:

a substantially flat gel carrying a fetal sensor for detecting at least one fetal parameter, said gel having a surface for securing the probe to a fetus to be monitored;

a substantially flat insulating layer disposed on said gel;

a substantially flat maternal sensor carried by said insulating layer for detecting at least one maternal parameter; and

means for communicating the fetal and maternal parameters comprising a fetal connector connecting said fetal sensor to said monitor and a maternal connector connecting said maternal sensor to said monitor, wherein said fetal connector and said maternal connector extend in a radial direction from said gel.

36. A non-invasive fetal probe as recited in claim 35 wherein said gel is a conductive hydrogel.

37. A non-invasive fetal probe as recited in claim 35 wherein said gel is an adhesive hydrogel.

38. A non-invasive fetal probe as recited in claim 35 wherein said gel is a conductive adhesive hydrogel.