Non-invasive fetal probe

• US 5,474,065 A
• Filed: 04/04/1994
• Issued: 12/12/1995
• Est. Priority Date: 04/04/1994
• Status: Expired due to Term

• Current Assignee: Graphic Controls Corporation (Nissha Co., Ltd.)
• Original Assignee: Graphic Controls Corporation (Nissha Co., Ltd.)
• Inventors: Meathrel, William G., Binks, Shirley A., Saleem, Mohammad
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US08/222,729
• Time in Patent Office: 617 Days
• Field of Search: 424/78.31, 424/78.35, 424/78.37, 424/443, 424/447, 607/138, 607/149, 607/152, 607/153, 128/639, 128/640, 128/642, 128/643, 128/641, 128/633, 128/634, 252/500, 252/521
• US Class Current: 600/376
• 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 5/4362 Assessing foetal parameters
• CPC Class Codes: Y10S 524/916 Hydrogel compositions
• CPC Class Codes: Y10T 428/31692 Next to addition polymer from unsaturated monomers
• CPC Class Codes: Y10T 428/31855 Of addition polymer from unsaturated monomers

Abstract

A non-invasive fetal probe attaching to the presenting part of a fetus and sensing at least one fetal parameter during labor and delivery. The body of the probe is formed of a conductive hydrogel which is adhesive to both wet and dry surfaces. The hydrogel is either formed into a suction cup shape or is coated on the inside surface of a suction cup shell. It is the combination of both the suction cup shape, which initially holds the probe to the fetus, and the hydrogel material, which allows for increased adhesion in the wet environment of the mother'"'"'s womb, which enables the probe to be securely attached to the fetus during labor and delivery. In one specific embodiment, the probe is a non-invasive fetal heart rate probe having a maternal heart rate sensor which detects the maternal heart rate to serve as a reference and a fetal heart rate sensor for monitoring the fetal heart rate. The maternal and fetal heart rate sensors are separated by an electrical insulation material which can form the suction cup.

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 body having a concave surface forming a suction cup adapted for securing the probe to the fetus to be monitored, and being comprised of a conductive hydrogel which is prepared from a precursor composition comprising acrylic acid and an alcoholamine and is adhesive under both wet and dry conditions;

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

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

2. A non-invasive fetal probe as recited in claim 1 wherein said alcoholamine of said hydrogel of said body is diisopropanolamine.

3. A non-invasive fetal probe as recited in claim 2 wherein said hydrogel of said body is prepared from water, acrylic acid, a photoinitiator, a crosslinking agent, diisopropanolamine, and an electrolyte.

4. A non-invasive fetal probe as recited in claim 3 wherein said hydrogel of said body is prepared from about 35-40% water, 15-30% acrylic acid, 0.3-0.4% photoinitiator, 0.05-0.20% crosslinking agent and 25-30% diisopropanolamine.

5. A non-invasive fetal probe as recited in claim 4 wherein said hydrogel of said body is prepared from about 39% water, 29% acrylic acid, 0.35% 2-hydroxy-2-methyl-1-phenyl-propane-1-one, 0.10% polyethylene glycol (400) diacrylate and 28% diisopropanolamine.

6. A non-invasive fetal probe as recited in claim 3 wherein said hydrogel of said body is prepared from about 38% water, 16% acrylic acid, 0.35% 2-hydroxy-2-methyl-1-phenyl-propane-1-one, 0.15% polyethylene glycol (400) diacrylate and 28% diisopropanolamine and 13% vinyl pyrrolidone.

7. A non-invasive fetal probe as recited in claim 1 wherein said body is "V"-shaped.

8. A non-invasive fetal probe as recited in claim 1 wherein said body has a diameter of 10-20 mm.

9. A non-invasive fetal probe as recited in claim 1 wherein said body further comprises a shell, said conductive hydrogel coated on said shell and forming said concave surface of said body facing the fetus.

10. A non-invasive fetal probe as recited in claim 9 wherein said shell is polymeric.

11. A non-invasive fetal probe as recited in claim 9 wherein said shell has an outer perimeter forming a member which is one of a ledge and a ridge isolating said conductive hydrogel from fluids in the environment surrounding the probe.

12. A non-invasive fetal probe as recited in claim 11 wherein said member formed by said outer perimeter of said shell is a ridge having a top edge and a lower edge and wherein said conductive hydrogel extends to said top edge of said ridge.

13. A non-invasive fetal probe as recited in claim 11 wherein said member formed by said outer perimeter of said shell is a ledge having a side surface, a top surface, and a bottom surface and wherein said conductive hydrogel is disposed on said top surface.

14. 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 body having a concave surface forming a suction cup adapted for securing the probe to the fetus to be monitored, and being comprised entirely of a conductive hydrogel which is adhesive under both wet and dry conditions;

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

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

15. A non-invasive fetal heart rate probe adapted for attachment to the presenting part of a fetus and monitoring a fetal heart rate during labor and delivery, said probe comprising:

a body having a concave surface forming a suction cup adapted for securing the probe to the fetus to be monitored, and being comprised of a conductive hydrogel which is adhesive under both wet and dry conditions;

a first sensor carried by said body and detecting a fetal heart rate;

means for communicating the fetal heart rate detected by said first sensor from said first sensor to a monitor;

a second sensor carried by said body and detecting reference signals;

means for communicating the reference signals detected by said second sensor from said second sensor to the monitor; and

means for electrically insulating said first sensor from said second sensor, said insulating means disposed between said first and said second sensors.

16. A non-invasive fetal heart rate probe as recited in claim 15 wherein said hydrogel of said body is prepared from at least acrylic acid and an alcoholamine.

17. A non-invasive fetal heart rate probe as recited in claim 16 wherein said alcoholamine of said hydrogel of said body is diisopropanolamine.

18. A non-invasive fetal heart rate probe as recited in claim 17 wherein said hydrogel of said body is prepared from water, acrylic acid, a photoinitiator, a crosslinking agent, diisopropanolamine and an electrolyte.

19. A non-invasive fetal heart rate probe as recited in claim 18 wherein said hydrogel of said body is prepared from about 35-40% water, 15-30% acrylic acid, 0.3-0.4% photoinitiator, 0.05-0.20% crosslinking agent and 25-30% diisopropanolamine.

20. A non-invasive fetal heart rate probe as recited in claim 19 wherein said hydrogel of said body is prepared from about 39% water, 29% acrylic acid, 0.35% 2-hydroxy-2-methyl-1-phenyl- propane-1-1one, 0.10% polyethylene glycol (400) diacrylate and 28% diisopropanolamine.

21. A non-invasive fetal heart rate probe as recited in claim 18 wherein said hydrogel of said body is prepared from about 38% water, 16% acrylic acid, 0.35% 2-hydroxy-2-methyl-1-phenyl-propane-1-one, 0.15% polyethylene glycol (400) diacrylate and 28% diisopropanolamine and 13% vinyl pyrrolidone.

22. A non-invasive fetal heart rate probe as recited in claim 15 wherein said body is "V"-shaped.

23. A non-invasive fetal heart rate probe as recited in claim 15 wherein said body has a diameter of 10-20 mm.

24. A non-invasive fetal heart rate probe as recited in claim 15 wherein said body is comprised entirely of said conductive hydrogel.

25. A non-invasive fetal heart rate probe as recited in claim 15 wherein said body further comprises a shell, said conductive hydrogel coated on said shell and forming said concave surface of said body facing the fetus.

26. A non-invasive fetal heart rate probe as recited in claim 15 wherein said shell is polymeric.

27. A non-invasive fetal heart rate probe as recited in claim 25 wherein said shell has an outer perimeter forming a member which is one of a ledge and a ridge isolating said conductive hydrogel from fluids in the environment surrounding the probe.

28. A non-invasive fetal heart rate probe as recited in claim 27 wherein said member formed by said outer perimeter of said shell is a ridge having a top edge and a lower edge and wherein said conductive hydrogel extends to said top edge of said ridge.

29. A non-invasive fetal heart rate probe as recited in claim 27 wherein said member formed by said outer perimeter of said shell is a ledge having a side surface, a top surface, and a bottom surface and wherein said conductive hydrogel is disposed on said top surface.

30. A non-invasive fetal heart rate probe as recited in claim 15 wherein said first sensor is embedded in said conductive hydrogel.

31. A non-invasive fetal heart rate probe adapted for attachment to the presenting part of a fetus and monitoring a fetal heart rate during labor and delivery, said probe comprising:

a body having a "V"-shaped suction cup adapted for securing the probe to the fetus to be monitored, said body having;

(a) a thermoplastic shell with an outer perimeter forming one of a ledge and a ridge, and

(b) a conductive hydrogel formed from the polymerization of a hydrogel precursor formulation comprising water, acrylic acid, a photoinitiator, a cross-linking agent, diisopropanolamine, and an electrolyte, said conductive hydrogel being adhesive under both wet and dry conditions, coated on said shell and forming a concave surface facing the fetus;

a first sensor carried by said body and detecting a fetal heart rate;

means for communicating the fetal heart rate detected by said first sensor from said first sensor to a monitor;

a second sensor carried by said body and detecting reference signals; and

means for communicating the reference signals detected by said second sensor from said second sensor to the monitor,

whereby one of said ledge and said ridge isolates said conductive hydrogel from fluids in the environment surrounding the probe.

32. 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 body having;

(a) a shell with an an outer perimeter forming a ridge having a top edge and a lower edge, and

(b) a concave surface forming a suction cup adapted for securing the probe to the fetus to be monitored, and

(c) a conductive hydrogel coated on said shell and forming said concave surface of said body, said conductive hydrogel being adhesive under both wet and dry conditions and extending to said top edge of said ridge and said ridge isolating said conductive hydrogel from fluids in the environment surrounding the probe;

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

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

33. 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 body having;

(a) a shell with an an outer perimeter forming a ledge having a side surface, a top surface, and a bottom surface, and

(b) a concave surface forming a suction cup adapted for securing the probe to the fetus to be monitored, and

(c) a conductive hydrogel coated on said shell and forming said concave surface of said body, said conductive hydrogel being adhesive under both wet and dry conditions and disposed on said top surface of said ledge and said ledge isolating said conductive hydrogel from fluids in the environment surrounding the probe;

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

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