Fetal sensor device

• US 5,425,362 A
• Filed: 07/30/1993
• Issued: 06/20/1995
• Est. Priority Date: 07/30/1993
• Status: Expired due to Term

• Current Assignee: Prothia
• Original Assignee: Criticare
• Inventors: Siker, Daniel, Lai, NC Joseph, Larsen, Michael T.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US08/100,607
• Time in Patent Office: 690 Days
• Field of Search: 128/634, 128/635, 128/642, 128/670, 128/698, 128/736, 128/662.06, 607/902
• US Class Current: 600/376
• CPC Class Codes: A61B 2503/02 Foetus
• CPC Class Codes: A61B 5/035 Intra-uterine probes therefor
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/1464 specially adapted for foetal tissue
• CPC Class Codes: A61B 5/288 for foetal cardiography, e.g. scalp electrodes
• CPC Class Codes: A61B 5/4362 Assessing foetal parameters
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: Y10S 607/902 Fetal monitoring other than heart rate

Abstract

An apparatus and method for noninvasively sensing parameters associated with the health of a fetus, the health of the placenta and the mother. The device includes a probe for inserting the sensor within the uterus of the mother, and the probe includes a flexible distal end portion having an independent inclination to assume an outward spiral curvature relative to the fetus. The probe has a transversely concave shaped channel to receive sensor cabling and control wires. The sensors can measure heart rate, oxygen saturation, temperature, chemical parameters, electroencephalogram activity and other useful parameters. The probe may also be used to infuse or remove fluid in the uterus.

Claims

1. A fetal sensor device for measuring biological parameters associated with a fetus, a placenta and a mother of the fetus, comprising:

means for noninvasively sensing parameters associated with at least one of the health of the fetus, the health of the placenta and of the mother bearing the fetus; and

probe means for inserting said means for sensing within a uterus of the mother, said probe means having a housing and including a flexible distal end portion integrally part of said probe means housing for positioning said means for sensing at a selected location in the mother and said distal end portion further having an independent inclination to assume an outward spiral curvature relative to the fetus.

2. The fetal sensor device as defined in claim 1 further including means for controlling curvature of said distal end portion of said probe means.

3. The fetal sensor device as defined in claim 1 wherein said distal end portion of said probe means includes a terminus and wherein said sensing means is disposed before said terminus of said distal end portion of said probe means.

4. The fetal sensor device as defined in claim 1 wherein said sensor means includes at least one of an ECG sensor, an EEG sensor, a temperature sensor, a pressure sensor, an oximetry sensor, an electrochemical sensor, a chemical sensor, and an ultrasound transducer array.

5. The fetal sensor device as defined in claim 4 wherein said chemical sensor comprises an ionic sensor for evaluating electrolyte compositions of amniotic fluid.

6. The fetal sensor device as defined in claim 1 wherein said probe means includes a longitudinal channel with a transversely concave surface for containing said sensor means.

7. The fetal sensor device as defined in claim 6 further including a sensor coupling disposed in said longitudinal channel and coupled to said means for sensing.

8. The fetal sensor device as defined in claim 1 further including an inflatable balloon device coupled to said probe means for directly sensing pressure.

9. The fetal sensor device as defined in claim 8 further including means for inflating said balloon device with dynamically variable pressures.

10. A method of sensing biologically useful parameters associated with a human fetus, comprising the steps of:

providing a probe having a housing including a flexible distal end portion and means for sensing the biologically useful parameters;

inserting said probe within the uterus of the fetus'"'"' mother to place said means for sensing at a selected location near the fetus;

positioning said means for sensing by using said flexible distal end portion having an independent inclination to assume an outward spiral curvature relative to the fetus; and

using said means for sensing to measure the biologically useful parameters.

11. The method as defined in claim 10 wherein the positioning step comprises locating said means for sensing near an ausculatory site of the fetus.

12. (Amended) The method as defined in claim 10 further including the step of providing an inflatable balloon coupled to said probe, said balloon enabling performing the additional step of measuring pressure near the fetus.

13. The method as defined in claim 10 further including the step of controlling the outward spiral curvature of said flexible distal end portion to enable firm positioning of said probe relative to the fetus.

14. The method as defined in claim 10 wherein said biologically useful parameters comprise at least one of oxygen content in the fetus'"'"' blood, temperature, ECG data and chemical parameters associated with the fetus.

15. The method as defined in claim 10 further comprising the step of providing said probe with a transversely concave surface enabling easy insertion of said probe into the uterus of the mother.

16. The method as defined in claim 10 further comprising the step of providing said probe with means for resisting expulsion from the uterus.

17. The method as defined in claim 16 further comprising the step of providing said means for resisting expulsion with an arrow tip structure disposed on said probe.

18. The method as defined in claim 16 further comprising the step of providing said means for resisting expulsion with a fish scale layer disposed on said probe.

19. The method as defined in claim 10 further including the step of responding to said biologically useful parameters to infuse or remove fluids from the uterus.

20. A method of sensing biologically useful parameters associated with a human fetus, comprising the steps of:

providing a probe having a housing including a flexible distal end portion and means for sensing the biologically useful parameters;

inserting said probe into a natural body cavity of the mother of the human fetus;

positioning said means for sensing by using said flexible distal end portion having an independent inclination to assume an outward spiral curvature within the natural body cavity; and

activating said means for sensing to measure the biologically useful parameter.

21. The method as defined in claim 20 further comprising the step of providing said probe with a longitudinal channel shaped device having a transversely concave surface.

22. The method as defined in claim 21 further comprising the step of dimensioning said device about 1-3 centimeters wide and about 20-35 centimeters long.

23. The method as defined in claim 22 further comprising the step of providing said device with a silicone based plastic covering over a spring steel strip.

24. The method as defined in claim 20 wherein the positioning step comprises locating said distal end portion at an ausculatory site of the human fetus.

25. The method as defined in claim 20 further comprising the step of providing said distal end portion with an arrowed portion for anchoring said probe.

26. The method as defined in claim 20 further comprising the step of providing said means for sensing with a sensor for determining motion artifacts.

27. The method as defined in claim 20 further comprising the step of providing said means for sensing with means for determining proximity of said housing to the human fetus.

28. The method as defined in claim 20 further comprising the step of providing said means for sensing with a light source and sensor for detecting the presence of artifacts arising from motion and thereby enabling correction of data characteristic of the biologically useful parameters.