Tool for placement of a monitoring probe in the scalp of a fetus

• US 4,913,151 A
• Filed: 01/05/1989
• Issued: 04/03/1990
• Est. Priority Date: 01/05/1989
• Status: Expired due to Fees

• Current Assignee: International Biomedics, Inc.
• Original Assignee: International Biomedics, Inc.
• Inventors: Harui, Norio, Hochberg, Howard M.
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): Getzow, Scott
• Application Number:
  US07/293,941
• Time in Patent Office: 453 Days
• Field of Search: 128/778, 128/698, 128/642, 128/633, 128/634, 128/785, 128/788
• US Class Current: 600/313
• CPC Class Codes: A61B 2503/02 Foetus
• 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

Abstract

The combination of a rigid, elongated applicator tool (200) and an elongated integral drive rod/probe (202). The drive rod/probe (202) is a rigid cable which includes a monitoring probe (204) with an extending spiral needle (206) at the front end thereof. At the rear end of the cable is a drive knob (236). The applicator tool (200) includes a hood element at the front end thereof which overlies the probe (204) and the needle (206) of the drive rod/probe (202) when the drive rod/probe (202) is positioned within the applicator tool (200). The applicator tool (200) includes a longitudinal slot (208) which permits insertion and removal of the drive rod/probe (202).

Claims

1. An article for securely attaching a monitoring device to the scalp of a fetus, comprising:

a probe including a spiral needle element and connections extending therefrom;

a drive element having a forward end supporting the probe and a rear end, the drive element being flexible along its length and containing therewithin said connections for the probe, the drive element including means in the vicinity of the rear end thereof for rotating the drive element and hence the probe;

a rigid applicator tool receiving the drive element and the probe, the applicator tool having a longitudinal slot along one side thereof of sufficient width to accommodate passage of the drive element therewithin.

2. The article of claim 1, wherein the applicator tool is angled.

3. The article of claim 1, wherein the drive element is a cable.

4. The article of claim 3, wherein the connections include at least a first and a second electrical connection for monitoring of ECG, and a fiberoptic connection for monitoring of pH.

5. The article of claim 4, wherein the probe includes a hub portion from which the spiral needle extends and a reference electrode portion at a rear of the hub portion, wherein the drive element fits securely within the reference electrode and wherein the first electrical connection includes an electrical conductor connected to the reference electrode and the second electrical connection includes an electrical conductor connected to the spiral needle element.

6. The article of claim 5, wherein the drive element is a cable which includes an interior sleeve, wherein the two electrical connections are wound around the interior sleeve, and wherein the fiberoptic connection extends interiorly of said sleeve.

7. The article of claim 6, wherein the cable includes a cable braid which provides torsional stiffness while maintaining low bend stiffness.

8. The article of claim 1, wherein the applicator tool includes a front end corresponding to the forward end of the drive element, and includes a hood element in the vicinity of the front end thereof, which overlays the probe and the spiral needle when the drive element is in position within the applicator tool and which assists in the positioning of the probe normal to the fetal scalp.

9. The article of claim 1, wherein said applicator tool includes a flexure joint at a selected location along its length.

10. The article of claim 1, including a plurality of gripping feet on a forward end of the probe, wherein the gripping feet have a blunt end and a sloping opposing end, so that rotation of the probe in the direction of the blunt end is difficult when the probe is inserted into the scalp of the fetus.

11. An article for securely attaching a probe to the scalp of a fetus, comprising:

a probe including means for attaching the probe to the scalp of a fetus;

an elongated drive element having a front end thereof, supporting the probe while the probe is being attached to the scalp of the fetus, wherein the drive element includes a joint along its length which separates the drive element into front and rear portions, wherein the front portion is hollow for receiving the probe therein and the rear portion is solid, wherein the joint is configured to permit the rear portion of the drive element to be angled relative to the front portion thereof without distortion of the front portion and without imparting a bending force to the front portion and further such that rotation of the rear portion results in corresponding rotation of the front portion without lateral movement of the front portion, including the probe, even when the rear portion is angled relative to the forward portion.

12. The article of claim 11, wherein the front portion of the drive element includes a front end, including a hood element around the front end of the front portion of the drive element for guiding the drive element and the probe to the scalp of the fetus, wherein the drive element and the hood element are configured and arranged to permit disengagement of the probe from the drive element.

13. The article of claim 12, wherein said joint includes two sets of opposing grooves positioned relatively close to each other and at 90°

relative to each other around the circumference of the drive element.

14. The article of claim 12, wherein said joint includes a plurality of grooves, arranged and configured such that the rear portion of the drive element may be moved relative to the joint in such a manner as to define a cone.

15. The article of claim 12, wherein the rear portion of the drive element includes a longitudinal slot therein opening onto the rear portion of the drive element, to accommodate a probe cable.

16. The article of claim 12, wherein the hood element and a portion of the drive element in the vicinity of the front end thereof each include a longitudinal slot for removal of the probe from the drive element.

17. The article of claim 13, wherein the hood element includes portions in the outer surface thereof configured so as to accommodate the fingers of a clinician user.

18. The article of claim 15, including means for holding at least one finger of the user in one of said portions in the outer surface of the hood element.

19. The article of claim 18, wherein said holding means includes an elastic band, said elastic band extending through an opening in the hood element, tending to maintain the band with the hood element.

20. The article of claim 17, wherein the front end of the hood element is configured to provide a frictional contact between the hood element and the fetal scalp, thus tending to maintain the scalp taunt underneath the hood element.

21. The article of claim 17, wherein the probe includes a needle portion extending therefrom and the hood element extends beyond the front end of the drive element to overlie the needle portion and thereby prevent contact between the needle portion and the tissues of the mother while the probe is being inserted.

22. The article of claim 21, wherein the interior surface of the drive element in the vicinity of the front end thereof is configured to mate with the exterior configuration of a portion of the probe.

23. A probe for monitoring a fetus, comprising:

a probe body having a forward end surface;

a spiral-shaped needle element which extends from the forward end surface of said probe body and away from said probe body; and

a plurality of generally saw-toothed shaped gripping feet members arranged at spaced intervals on the forward end surface of the probe body, the gripping feet each having a sloping leading end and an opposing blunt trailing end, so as to substantially prevent the probe body from being turned in a direction opposite from that for insertion of the probe body, following insertion of the probe body into the scalp of the fetus.

24. The article of claim 23, wherein the gripping feet are approximately 0.03 inches high and the sloping leading end has an angle of approximately 15°

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