Intrauterine probe

• US 5,025,787 A
• Filed: 02/26/1990
• Issued: 06/25/1991
• Est. Priority Date: 10/08/1986
• Status: Expired due to Term

• Current Assignee: British Technology Group Ltd.
• Original Assignee: Imperial College of Science Technology & Medicine (Imperial College London)
• Inventors: Sutherland, Ian A., Steer, Philip J., Randall, Nigel J.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Pontius, Kevin
• Application Number:
  US07/484,956
• Time in Patent Office: 484 Days
• Field of Search: 128/639, 128/642, 128/698, 128/748, 128/775
• US Class Current: 600/376
• 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

Abstract

A method of and apparatus for monitoring the condition of a fetus during labor includes an elongated flexible, flattened body member formed from an electrically insulating material having a rounded distal end and having at least oen sensor mounted in a flat face of the body member. The body member is sufficiently directionally stable to be insertable into the vaginal tract and through the cervix and is capable of being guided around the fetus without twisting. The body member has a bending stiffness about an axis transverse to the plane of the body member of between 1 and 10 megaNewtons/m². Once the apparatus is introduced into the cervix, the signal ouptut from at least one electrode is analyzed by discriminating the fetal heart rate from the maternal heart rate.

Claims

1. An intrauterine probe for monitoring the condition of a fetus during labor, comprising:

an elongate flexible, flattened body member formed from electrically insulating material and having a rounded distal end, and having at least one sensor mounted in a flat face of the body member, said body member having a bending stiffness about an axis transverse to the plane of said body member of between 1 and 10 megaNewtons/m², whereby said body member is sufficiently directionally stable to be insertable into the vaginal tract and through the cervical OS and capable of being guided around the fetus without twisting.

2. A probe according to claim 1, including a distal sensor, and at least two additional sensors located in a group, wherein a spacing, lengthwise of said body member, between said distal sensor and the proximal additional sensors being greater than a spacing between said at least two additional sensors in the group.

3. A probe according to claim 2, wherein at least one of said sensors comprises an electrode for detecting fetal hear rate.

4. A probe according to claim 1, wherein said at least one sensor comprises a pressure transducer.

5. A probe according to claim 1, wherein portions of said electrically insulating material encircling said at least one sensor comprise a resilient foam material having non-communicating cells.

6. A probe according to claim 1, wherein portions of said electrically insulating material bounding said at least one sensor have a rounded upper surface in cross-section.

7. A probe according to claim 1, comprising at least two sensors spaced longitudinally thereof in at least one flat face of said body member.

8. A probe according to claim 7, wherein one of said at least two sensors comprises a distal sensor, said distal sensor being a pressure transducer.

9. A probe according to claim 1, wherein said electrically insulating material comprises polyurethane.

10. A probe according to claim 1, further comprising a processor, which is in structural communication with said at least one sensor, and which is adapted to distinguish between signals representing a fetal heart rate and a maternal heart rate.

13. A probe according to claim 3, wherein said first electrode is for detecting fetal heart rate and is located in one face of said body member, and said second electrode is for detecting maternal heart rate and is located in a second face of said body member.

14. A probe according to claim 13, further comprising a third reference electrode mounted in one face of said body member and spaced longitudinally of said body member from each of said first and second electrodes by a distance which is greater than a distance between said first and second electrodes.

11. An intrauterine probe for monitoring the condition of a fetus during labor, comprising:

an elongate flexible, flattened body member formed from electrically insulating material and having a rounded distal end, and at least one electrode located in one flat face of said body member;

said body member having a bending stiffness about an axis transverse to the plane of said body member of between 1 and 10 megaNewtons/m², whereby said body member is sufficiently directionally stable to be insertable into the vaginal tract and through the cervical OS and capable of being guided around the fetus without twisting;

and said at least one electrode being mounted in said body member so as to be in close proximity to the fetal skin.

12. An intrauterine probe for monitoring fetal heart rate during labor, comprising:

an elongate flexible, flattened body member formed from electrically insulating material and having a rounded distal end, and at least first and second electrodes each of which are located in one flat face of the body member and being spaced longitudinally of;

said body member having a bending stiffness about an axis transverse to the plane of said body member of between 1 and 10 megaNewtons/m², whereby said body member is sufficiently directionally stable to be insertable into the vaginal tract and through the cervical OS and capable of being guided around the fetus without twisting;

and each electrode being mounted in said body member so as to be in close proximity to the fetal skin.

15. A probe according to claim 12, including a plurality of electrodes in one flat face of said body member, said electrodes being spaced over a distance which, in use, is sufficient to encompass the fetal head, neck and back.

16. An intrauterine probe for monitoring fetal heart rate during labor, comprising:

an elongate flexible, flattened body member formed from electrically insulating material and having a rounded distal end;

said body member having a bending stiffness about an axis transverse to the plane of said body member of between 1 and 10 megaNewtons/m², whereby said body member is sufficiently directionally stable to be insertable into the vaginal tract and through the cervical OS and capable of being guided around the fetus without twisting;

and at least two longitudinally spaced electrodes located in one face thereof, each electrode being mounted in said body member so as to be pressed into close proximity with fetal skin and having a portion of insulating material between said electrodes, said portion having a profile such that in use the amniotic fluid present between said electrodes is reduced to a thin electrolyte film having a high electrical impedance.

17. A method of monitoring fetal heart rate during labor, said method comprising the steps of:

introducing into the cervix a probe including an elongate, flexible, flattened body member formed from electrically insulating material;

said body member having a bending stiffness about an axis transverse to the plane of said body member of between 1 and 10 megaNewtons/m², whereby said body member is sufficiently directionally stable to be insertable into the vaginal tract and through the cervical OS and capable of being guided around the fetus without twisting;

and having at least one electrode located in one face thereof; and

analyzing the signal output from said at least one electrode by discriminating said fetal heart rate from a maternal heart rate based on at least one of a difference in ECG R wave signal width and frequency.