Fetal electrode product with channeled drive mechanism and improved torque characteristics

• US 5,388,579 A
• Filed: 09/23/1993
• Issued: 02/14/1995
• Est. Priority Date: 09/23/1993
• Status: Expired due to Term

• Current Assignee: Graphic Controls Corporation (Nissha Co., Ltd.)
• Original Assignee: Graphic Controls Corporation (Nissha Co., Ltd.)
• Inventors: Eichelberger, Cleatis A., Dowd, Edward, O'Neill, Joseph, DiSabito, David M., Hubbard, James R.
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): GREEN, BRIAN
• Application Number:
  US08/126,218
• Time in Patent Office: 509 Days
• Field of Search: 128/632, 128/633, 128/634, 128/635, 128/666, 128/642, 128/783, 128/784, 128/785, 128/786, 128/639, 128/640, 128/641, 439/909
• US Class Current: 600/376
• 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: Y10S 439/909 Medical use or attached to human body

Abstract

A fetal electrode product for transmitting signals indicative of fetal heart rate from a fetus to a monitor. A drive mechanism slides and rotates a holder--to which are attached, at opposite ends, a fetal spiral electrode (FSE) and a reference electrode--to secure the FSE to the fetus. The drive mechanism has a solid drive rod, with at least two regions of different diameter defining the torque versus angular deflection characteristics of the drive rods and a clutch connected to the drive rod and imparting translation and rotation to the holder. The clutch is sufficiently pliable to slip over the reference electrode when the holder resists rotation. The drive rod, a handle, and the clutch are integrally molded together to form the drive mechanism and each has a channel transporting a twisted wire strand, which includes an untwisted length to facilitate removal of the FSE from the fetus, from the electrodes to a connector. The connector has an outside dimension greater than the outside diameter of the drive rod to facilitate handling and smaller than the inside diameter of an annular guide tube so that the guide tube can be pulled over the connector after the FSE is attached to the fetus. The connector also has a plug and grip sized to provide a visual indication of full insertion of the plug into the socket opening of a support plate affixed to the mother and electrically connected to the monitor.

Claims

1. A fetal electrode product for transmitting signals indicative of fetal heart rate from a fetus to a monitor, said product comprising:

a fetal spiral electrode, a maternal reference electrode, and a holder made of an insulating material, said electrodes mounted on opposite ends of said holder;

a twisted wire strand including a pair of wires respectively connected to said fetal spiral electrode and said maternal reference electrode and adapted to connect said fetal spiral electrode and said maternal reference electrode to the monitor; and

a drive mechanism connected to said holder when sliding and rotating said holder to secure attachment of said fetal spiral electrode to the fetus, said drive mechanism having;

(a) a solid drive rod with a forward end, a rearward end, a region of smaller diameter having a diameter and a region of larger diameter having a diameter, said regions defining the torque versus angular deflection characteristics of said drive rod,

(b) a handle connected to said rearward end of said drive rod and imparting translation and rotation to said drive rod, and

(c) a clutch connected to said forward end of said drive rod and adapted to impart translation and rotation to said holder,

each of said drive rod, said handle, and said clutch having a channel adapted to transport said twisted wire strand from said electrodes to the monitor and said region of smaller diameter having a plurality of journals spaced along its length, said journals having an outer diameter larger than the diameter of said region of smaller diameter, a notch corresponding to the width of said channel, and a height tangent to said twisted wire strand transported in said channel.

2. The fetal electrode product in accordance with claim 1 further comprising an annular guide tube having an inside diameter only slightly greater than the diameter of said region of larger diameter and adapted to be comfortably inserted through the cervix of a mother in labor, said guide tube slidably arranged around said drive rod.

3. The fetal electrode product in accordance with claim 2 wherein said drive rod has a third region with a diameter larger than the diameter of said region of smaller diameter and smaller than the diameter of said region of larger diameter.

4. The fetal electrode product in accordance with claim 1 further comprising an annular guide tube having an inside diameter and adapted to be comfortably inserted through the cervix of a mother in labor, said guide tube slidably arranged around said drive rod and said region of smaller diameter having a number of second journals spaced along its length with an outer diameter only slightly less than the inside diameter of said guide tube.

5. The fetal electrode product in accordance with claim 1 wherein said solid drive rod, said handle, and said clutch are integrally molded together to form said drive mechanism.

6. The fetal electrode product in accordance with claim 5 wherein said drive mechanism is formed from a polymer selected from the group consisting of polyethylene and polypropylene.

7. The fetal electrode product in accordance with claim 5 further comprising a ramp disposed between and connecting said drive rod and said clutch and an incline disposed between and connecting said drive rod and said handle.

8. The fetal electrode product in accordance with claim 1 wherein said twisted wire strand has an untwisted length.

9. The fetal electrode product in accordance with claim 1 wherein said clutch has a pair of arms defining a pair of slots releasably engaging and centering said maternal reference electrode for transmitting torque between said drive rod and said holder, said arms being pliable and slipping over said maternal reference electrode when said holder resists rotation.

10. A fetal electrode product for transmitting signals indicative of fetal heart rate from a fetus to a monitor, said product comprising:

a fetal spiral electrode and a maternal reference electrode;

a support plate adapted to be affixed to the mother and having a housing and first and second terminals within a socket opening in said housing, said first and second terminals adapted to be electrically connected to the monitor;

a connector having;

(a) a plug of a predetermined length with a first contact and a second contact spaced from each other and a tip and a rear, one of said contacts engaging one of said first and second terminals and the other of said contacts engaging the other of said first and second terminals when said connector is inserted fully into said socket opening of said support plate,

(b) a grip of larger diameter than said plug arranged at said rear of said plug, and

(c) a shoulder between said plug and said grip, said length of said plug predetermined so that said shoulder of said connector abuts said housing of said support plate when said connector is fully inserted into said socket opening; and

a twisted wire strand including a pair of wires respectively connecting (a) one of said fetal spiral electrode and said maternal reference electrode to one of said first and said second contacts and (b) the other of said fetal spiral electrode and said maternal reference electrode to the second of said first and said second contacts.

11. The fetal electrode product in accordance with claim 10 further comprising:

a holder made of an insulating material, said electrodes mounted on opposite ends of said holder; and

a drive mechanism connected to said holder when sliding and rotating said holder to secure attachment of said fetal spiral electrode to the fetus, said drive mechanism having;

(a) a solid drive rod with a forward end, a rearward end, a region of smaller diameter having a diameter and a region of larger diameter having a diameter, said regions defining the torque versus angular deflection characteristics of said drive rod,

(b) a handle connected to said rearward end of said drive rod and imparting translation and rotation to said drive rod, and

(c) a clutch connected to said forward end of said drive rod and adapted to impart translation and rotation to said holder,

each of said drive rod, said handle, and said clutch having a channel adapted to transport said twisted wire strand from said electrodes to said connector.

12. The fetal electrode product in accordance with claim 11 wherein said region of smaller diameter has a plurality of journals spaced along its length, said journals having an outer diameter larger than the diameter of said region of smaller diameter, a notch corresponding to the width of said channel, and a height tangent to said twisted wire strand transported in said channel.

13. The fetal electrode product in accordance with claim 12 further comprising an annular guide tube having an inside diameter only slightly greater than the diameter of said region of larger diameter and adapted to be comfortably inserted through the cervix of a mother in labor, said guide tube slidably arranged around said drive rod.

14. The fetal electrode product in accordance with claim 13 wherein said drive rod has a third region with a diameter larger than the diameter of said region of smaller diameter and smaller than the diameter of said region of larger diameter.

15. The fetal electrode product in accordance with claim 12 further comprising an annular guide tube having an inside diameter and adapted to be comfortably inserted through the cervix of a mother in labor, said guide tube slidably arranged around said drive rod and said region of smaller diameter having a number of second journals spaced along its length with an outer diameter only slightly less than the inside diameter of said guide tube.

16. The fetal electrode product in accordance with claim 11 wherein said solid drive rod, said handle, and said clutch are integrally molded together to form said drive mechanism.

17. The fetal electrode product in accordance with claim 16 wherein said drive mechanism is formed from a polymer selected from the group consisting of polyethylene and polypropylene.

18. The fetal electrode product in accordance with claim 16 further comprising a ramp disposed between and connecting said drive rod and said clutch and an incline disposed between and connecting said drive rod and said handle.

19. The fetal electrode product in accordance with claim 11 wherein said twisted wire strand has an untwisted length.

20. The fetal electrode product in accordance with claim 11 wherein said clutch has a pair of arms defining a pair of slots releasably engaging and centering said maternal reference electrode for transmitting torque between said drive rod and said holder, said arms being pliable and slipping over said maternal reference electrode when said holder resists rotation.

21. A fetal electrode product for transmitting signals indicative of fetal heart rate from a fetus to a receiver, said product comprising:

an unslotted annular guide tube having an inside diameter and adapted to be comfortably inserted through the cervix of a mother in labor;

a fetal spiral electrode, a maternal reference electrode, and a holder slidably and rotatably disposed in said guide tube and made of an insulating material, said electrodes mounted on opposite ends of said holder;

a drive mechanism connected to said holder when sliding and rotating said holder to secure attachment of said fetal spiral electrode to the fetus, said drive mechanism having;

(a) a solid drive rod with an outside diameter, a forward end and a rearward end,

(b) a handle connected to said rearward end of said drive rod and imparting translation and rotation to said drive rod, and

(c) a clutch connected to said forward end of said drive rod and adapted to impart translation and rotation to said holder,

said drive mechanism having a channel longitudinally disposed in each of said drive rod, said handle, and said clutch;

a connector having an outside dimension at least equal to said outside diameter of said solid drive rod to facilitate handling and smaller than said inside diameter of said annular guide tube so that said guide tube can be pulled over said connector after said fetal spiral electrode is attached to the fetus, said connector including at least two contacts separated and electrically isolated from each other for transmitting said signals to said receiver; and

a twisted wire strand including a pair of wires respectively connecting (a) one of said fetal spiral electrode and said maternal reference electrode to one of said contacts and (b) the other of said fetal spiral electrode and said maternal reference electrode to the second of said contacts, said twisted wire strand disposed along said channel of said drive mechanism.

22. The fetal electrode product in accordance with claim 21 wherein said drive rod has a region of smaller diameter having a diameter and a region of larger diameter having a diameter, said regions defining the torque versus angular deflection characteristics of said drive rod.

23. The fetal electrode product in accordance with claim 22 wherein said region of smaller diameter has a plurality of journals spaced along its length, said journals having an outer diameter larger than the diameter of said region of smaller diameter, a notch corresponding to the width of said channel, and a height tangent to said twisted wire strand transported in said channel.

24. The fetal electrode product in accordance with claim 23 wherein the diameter of said region of larger diameter is only slightly less than the inside diameter of said guide tube.

25. The fetal electrode product in accordance with claim 24 wherein said drive rod has a third region with a diameter larger than the diameter of said region of smaller diameter and smaller than the diameter of said region of larger diameter.

26. The fetal electrode product in accordance with claim 23 wherein said region of smaller diameter has a number of second journals spaced along its length with an outer diameter only slightly less than the inside diameter of said guide tube.

27. The fetal electrode product in accordance with claim 22 wherein said solid drive rod, said handle, and said clutch are integrally molded together to form said drive mechanism.

28. The fetal electrode product in accordance with claim 27 wherein said drive mechanism is formed from a polymer selected from the group consisting of polyethylene and polypropylene.

29. The fetal electrode product in accordance with claim 27 further comprising a ramp disposed between and connecting said drive rod and said clutch and an incline disposed between and connecting said drive rod and said handle.

30. The fetal electrode product in accordance with claim 22 wherein said twisted wire strand has an untwisted length.

32. A fetal electrode product for transmitting signals indicative of fetal heart rate from a fetus to a monitor, said product comprising:

an unslotted annular guide tube having an inside diameter and adapted to be comfortably inserted through the cervix of a mother in labor;

a fetal spiral electrode, a maternal reference electrode, and a holder slidably and rotatably disposed in said guide tube and made of an insulating material, said electrodes mounted on opposite ends of said holder;

a support plate adapted to be affixed to the mother and having a housing and first and second terminals within a socket opening in said housing, said first and second terminals adapted to be electrically connected to the monitor;

a drive mechanism connected to said holder when sliding and rotating said holder to secure attachment of said fetal spiral electrode to the fetus, said drive mechanism having;

(a) a solid drive rod with an outside diameter, a forward end, a rearward end, and at least two regions of different diameter, said regions defining the torque versus angular deflection characteristics of said drive rod,

(b) a handle connected to said rearward end of said drive rod and imparting translation and rotation to said drive rod, and

(c) a clutch connected to said forward end of said drive rod and adapted to impart translation and rotation to said holder,

said drive mechanism having a channel longitudinally disposed in each of said drive rod, said handle, and said clutch;

a connector having;

(a) a plug of a predetermined length with a first contact and a second contact spaced from each other and a tip, one of said contacts engaging one of said first and second terminals and the other of said contacts engaging the other of said first and second terminals when said connector is inserted fully into said socket opening of said support plate,

(b) a grip with a diameter larger than said plug, greater than said outside diameter of said solid drive rod to facilitate handling, and smaller than said inside diameter of said annular guide tube so that said guide tube can be pulled over said connector after said fetal spiral electrode is attached to the fetus, and

(c) a shoulder between said plug and said grip, said length of said plug predetermined so that said shoulder of said connector abuts said housing of said support plate when said connector is fully inserted into said socket opening; and

a twisted wire strand including a pair of wires respectively connecting (a) one of said fetal spiral electrode and said maternal reference electrode to one of said contacts and (b) the other of said fetal spiral electrode and said maternal reference electrode to the second of said contacts, said twisted wire strand disposed along said channel of said drive mechanism.

31. The fetal electrode product in accordance with claim 32 wherein said clutch has a pair of arms defining a pair of slots releasably engaging and centering said maternal reference electrode for transmitting torque between said drive rod and said holder, said arms being pliable and slipping over said maternal reference electrode when said holder resists rotation.