Multiparameter fetal monitoring device

• US 6,115,624 A
• Filed: 07/29/1998
• Issued: 09/05/2000
• Est. Priority Date: 07/30/1997
• Status: Expired due to Fees

• Current Assignee: Genesis Technologies, Inc.
• Original Assignee: Genesis Technologies, Inc.
• Inventors: Lewis, Donald E., Park, Randall I., Park, George D.
• Primary Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US09/124,935
• Time in Patent Office: 769 Days
• Field of Search: 600/511, 600/376, 600/509, 600/514
• US Class Current: 600/376
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/02156 Calibration means
• CPC Class Codes: A61B 5/035 Intra-uterine probes therefor
• 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 7/04 Electric stethoscopes microphones, acoustic transducers therefor H04R
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end

Abstract

An intrauterine catheter device for monitoring fetal and/or maternal heart rate, including an elongate housing having proximal and distal portions, an array of ECG electrodes on the distal portion and one or more acoustic or other mechanical sensors on the distal portion. A pressure transducer may also be provided on the distal portion. Processor circuitry compares the ECG signal with the output signal of the acoustic sensor to derive fetal and/or maternal heart rate. An intrauterine catheter device is also provided, including a reference electrode on its distal portion, and an array of active electrodes spaced apart from one another on the distal portion. The device may also include a pressure transducer on the distal portion and processor circuitry coupled to the array of active electrodes and/or to the reference electrode for deriving fetal ECG from signals produced by the array of active electrodes. Alternatively, the array of electrodes and acoustic sensors may be provided on a flexible pad that may be secured to the abdomen of a pregnant mother. An intrauterine catheter device is also provided, including a plurality of lumens communicating with a differential pressure transducer provided on its distal portion, and having a zeroing switch on its proximal portion for resetting the pressure transducer in situ.

Claims

1. An intrauterine catheter device for monitoring a fetus in utero, comprising:

an elongate housing having a proximal portion and a distal portion adapted for insertion into a pregnant mother'"'"'s uterus;

an array of electrodes on the distal portion adapted to produce an ECG signal; and

a mechanical sensor on the distal portion, the mechanical sensor being adapted to produce an output signal including a fetal heart rate signal.

2. The intrauterine catheter device of claim 1, wherein the mechanical sensor comprises an acoustic sensor.

3. The intrauterine catheter device of claim 1, wherein the mechanical sensor comprises a hydrophone device.

4. The intrauterine catheter device of claim 1, wherein the mechanical sensor comprises a micro-gyroscope.

5. The intrauterine catheter device of claim 1, wherein the mechanical sensor comprises a micro-accelerometer.

6. The intrauterine catheter device of claim 1, further comprising a pressure transducer on the distal portion for measuring intrauterine pressure.

7. The intrauterine catheter device of claim 1, further comprising one or more connectors on the proximal portion coupled to the array of electrodes and the mechanical sensor.

8. The intrauterine catheter device of claim 1, further comprising processor circuitry for comparing the ECG signal to the output signal of the mechanical sensor to derive fetal heart rate information.

9. A system for monitoring fetal heart rate, comprising:

an array of electrodes spaced apart from one another;

one or more mechanical sensors adjacent to the array of electrodes; and

processor circuitry for comparing an ECG signal produced by the array of electrodes with a signal produced by the one or more mechanical sensors to derive fetal heart rate information.

10. The system of claim 9, further comprising a monitoring device coupled to the processor circuitry for displaying the fetal heart rate information.

11. The system of claim 10, further comprising interface circuitry coupled to the processor circuitry and the monitoring device for communicating therebetween.

12. The system of claim 9, further comprising a pad having a lower surface that may be applied to the abdomen of a pregnant mother, the array of electrodes and the one or more mechanical sensors being located on the lower surface of the pad.

13. The system of claim 9, further comprising an elongate member having a distal portion adapted for insertion into a pregnant mother'"'"'s uterus, the array of electrodes and the one or more mechanical sensors being located on the distal portion.

14. The system of claim 13, further comprising a pressure transducer on the distal portion.

15. A method for deriving fetal heart rate of a fetus in a pregnant mother'"'"'s uterus, using a device including an array of electrodes and an acoustic sensor thereon, the method comprising the steps of:

placing the device adjacent the fetus;

detecting ECG activity within the uterus with the array of electrodes, the array of electrodes producing an ECG signal corresponding to the ECG activity;

detecting acoustic activity within the uterus with the acoustic sensor, the acoustic sensor producing an acoustic signal corresponding to the acoustic activity; and

comparing the ECO signal and acoustic signal to derive the fetal heart rate.

16. The method of claim 15, wherein the device has a distal portion with the array of electrodes and the acoustic sensor thereon, and wherein the distal portion is advanced into the pregnant mother'"'"'s uterus when the device is placed adjacent the fetus.

17. The method of claim 15, wherein the device is a substantially flexible pad having a lower surface with the array of electrodes and the acoustic sensor thereon, and wherein the lower surface is placed against the abdomen of the pregnant mother when the device is placed adjacent the fetus.

18. The method of claim 15, comprising the additional step of comparing the ECG signal and acoustic signal to derive a maternal heart rate of the pregnant mother.

19. The method of claim 15, comprising the additional step of displaying the fetal heart rate on a monitoring device.

20. An intrauterine catheter device for monitoring a fetus during labor, comprising:

an elongate housing having a proximal portion and a distal portion adapted for insertion into a pregnant mother'"'"'s uterus;

a reference electrode on the distal portion; and

an array of active electrodes spaced apart from one another on the distal portion, wherein the array of active electrodes includes a bipolar pair of electrodes.

21. The intrauterine catheter device of claim 20, wherein the array of active electrodes comprises a plurality of electrodes spaced apart axially from one another.

23. The intrauterine catheter device of claim 20, further comprising a pressure transducer on the distal portion.

24. The intrauterine catheter device of claim 20, further comprising processor circuitry coupled to the array of active electrodes and the reference electrode for deriving fetal heart rate information from a signal produced by the array of active electrodes.

22. An intrauterine catheter device for monitoring a fetus during labor, comprising:

an elongate housing having a proximal portion and a distal portion adapted for insertion into a pregnant mother'"'"'s uterus,

a reference electrode on the distal portion; and

an array of active electrodes spaced apart from one another on the distal portion, wherein the array of active electrodes comprises a pair of electrodes provided back-to-back from one another.

25. An intrauterine catheter device for monitoring a fetus during labor, comprising:

an elongate housing having a proximal portion and a distal portion adapted for insertion into a pregnant mother'"'"'s uterus, and including first and second lumens extending between the proximal and distal portions;

a differential pressure transducer on the distal portion, the transducer having a front side exposed on the distal portion, and a back side disposed within the distal portion, the first and second lumens being in communication with the front and back sides, respectively; and

a zeroing switch on the proximal portion of the housing, the zeroing switch being adjustable between first and second positions, whereby in the first position the second lumen is in communication with external atmospheric pressure, and whereby in the second position the second lumen is in communication with the first lumen.

26. The intrauterine catheter device of claim 25, further comprising one or more mechanical sensors on the distal portion.

27. The intrauterine catheter device of claim 25, further comprising an array of ECG electrodes spaced apart from one another on the distal portion.

28. The intrauterine catheter device of claim 25, further comprising a third lumen extending between the proximal and distal portions, the third lumen being connected to the first lumen at a location proximate to the front side of the pressure transducer.

29. The intrauterine catheter device of claim 28, wherein the zeroing switch is adjustable to a third position such that the first lumen is in communication with a port on the zeroing switch, the port being connectable to a source of pressure for forcing fluid from the first lumen.

30. A device for monitoring a fetus in utero, comprising:

a flexible pad having a lower surface for contacting a pregnant mother'"'"'s abdomen;

an array of electrodes on the lower surface adapted to produce an ECG signal,

one or more mechanical sensors on the lower surface adapted to produce an output signal including a fetal heart rate signal; and

processor circuitry for comparing the ECG signal to the output signal of the mechanical sensors to derive fetal heart rate information.

31. The device of claim 30, wherein the mechanical sensors comprises an acoustic sensor.